What is Advil-Migraine

Advil-Migraine is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen and is available over-the-counter to relieve pain, treats migraine and reduce fever. Advil-Migraine (ibuprofen) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, fever and pain caused by inflammation. Advil-Migraine (ibuprofen) also helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. Advil-Migraine does not cure arthritis and will help you only as long as you continue to take it. In addition, Advil-Migraine (ibuprofen) can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor.

You can buy most types of Advil-Migraine (ibuprofen) from pharmacies and supermarkets. Some types are only available on prescription.

Advil-Migraine (ibuprofen) works by inhibiting the enzymes Cyclooxygenase 1 (COX-1) and Cyclooxygenase 2 (COX-2) by reducing hormones prostaglandin that cause inflammation, fever and pain in your body ¹. Advil-Migraine (ibuprofen) reduces the ability of your body to make prostaglandins – chemicals that promote pain, inflammation and fever. With fewer prostaglandins in your body, fever eases off, and pain and inflammation is reduced. Cyclooxygenase 1 (COX-1) is constitutively active and is expressed in most tissues, including kidney, lung, stomach, duodenum, jejunum, ileum, colon, and cecum. Cyclooxygenase 1 (COX-1) functions in gastric cytoprotection, vascular homeostasis, platelet aggregation, and maintenance of normal kidney function ². Cyclooxygenase 2 (COX-2) is an inducible enzyme expressed in the brain, kidney, and possibly in the female reproductive system ². Cyclooxygenase 2 (COX-2) expression is increased during states of inflammation ³. Cyclooxygenase 2 (COX-2) is a key source of prostacyclin (PGI2) and is cardioprotective in ischemia–reperfusion injury ³. Advil-Migraine (ibuprofen) analgesic activity is primarily (although not exclusively) associated with inhibition of COX-2, while different side effects result from the inhibition of COX-1 and COX-2 ⁴.

Key facts

• Advil-Migraine (ibuprofen) takes 20 to 30 minutes to work if you take it by mouth.
• Advil-Migraine (ibuprofen) works by reducing hormones that cause pain and swelling in the body.
• Taking any form of painkiller frequently can make migraines worse. This is sometimes called “medication overuse headache” or “painkiller headache”.
• Speak to your doctor if you find yourself needing to use painkillers repeatedly or if over-the-counter painkillers aren’t effective. Your doctor may prescribe stronger painkillers or recommend using painkillers along with triptans (see below). If they suspect the frequent use of painkillers may be contributing your headaches, they may recommended that you stop using them.
• Always take Advil-Migraine (ibuprofen) tablets and capsules with food or a drink of milk to reduce the chance of an upset tummy. Don’t take it on an empty stomach.
• If you’re taking tablets, take the lowest dose for the shortest time. Don’t use it for a long time unless you’ve talked about it with your doctor.
• If the treatments above aren’t effectively controlling your migraines, your doctor may refer you to a specialist migraine clinic for further investigation and treatment. A specialist may recommend other treatments such as transcranial magnetic stimulation.
• Transcranial magnetic stimulation involves holding a small electrical device to your head that delivers magnetic pulses through your skin. It’s not clear exactly how transcranial magnetic stimulation works in treating migraines, but studies have shown that using it at the start of a migraine can reduce its severity. It can also be used in combination with the medications mentioned above without interfering with them. However, transcranial magnetic stimulation isn’t a cure for migraines and it doesn’t work for everyone. The evidence for its effectiveness isn’t strong and is limited to people who have migraine with aura. There’s also little evidence about the potential long-term effects of the treatment, although studies into the treatment have so far only reported minor and temporary side effects, including:
  • slight dizziness
  • drowsiness and tiredness
  • a muscle tremor that can make it difficult to stand
  • irritability

How long does it take for Advil-Migraine to work?

You should start to feel better 20 to 30 minutes after taking Advil-Migraine (ibuprofen) by mouth.

Advil-Migraine vs Advil

Advil-Migraine contains the same amount of the active ingredient 200 mg ibuprofen as the standard Advil, except Advil-Migraine has the solubilized version of the ibuprofen, which may have a quicker onset.

Can you take Excedrin-Migraine with Advil?

No, because Excedrin-Migraine contains aspirin which belongs to the same group of medicine as Advil (ibuprofen) called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Advil-Migraine (ibuprofen) plus aspirin (Excedrin-Migraine) may increase the chance of you getting side effects like stomach ache.

Taking Advil-Migraine with other painkillers

It’s safe to take Advil-Migraine (ibuprofen) with acetaminophen or codeine.

But don’t take Advil-Migraine (ibuprofen) with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Advil-Migraine (ibuprofen), aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Advil-Migraine (ibuprofen) plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to Advil-Migraine

For treating fever, an alternative to Advil-Migraine (ibuprofen) is acetaminophen (Tylenol).

For pain or inflammation-related swelling, ask your doctor or pharmacist for an alternative if Advil-Migraine (ibuprofen) is not suitable for you. Your health professional may suggest you try:

• acetaminophen (paracetamol)
• another medicine from the NSAID family
• a medicine that combines codeine with acetaminophen in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever.

Treating migraine without medicine

The following non-medicine treatments may help you to prevent frequent or troublesome migraines — you can use them either instead of, or as well as, medicine treatments:

• physical therapies (eg, physiotherapy or chiropractic treatment), especially if neck problems are thought to be contributing to your migraines — it’s essential to seek out a therapist with specialist training in this area, however, as there have been very rare reports of stroke after spinal manipulation of the neck
• physical exercise
• relaxation training (eg, yoga, meditation), which can help manage underlying problems with stress
• cognitive behavioral therapy (CBT), a psychological therapy that teaches you to identify and challenge stress generating thoughts
• acupuncture. If medication is unsuitable, or it doesn’t help to prevent migraines, you may want to consider acupuncture.

Medicines for an acute migraine attack

There’s currently no cure for migraines, although a number of treatments are available to help ease the symptoms.

Most people find that sleeping or lying in a darkened room is the best thing to do when having a migraine attack.

Others find that eating something helps, or they start to feel better once they’ve been sick.

It may take time to work out the best treatment for you. You may need to try different types or combinations of medicines before you find the most effective ones.

Doctors recommend a stepped approach to treatment for acute migraine attack; that is, trying the simplest remedy first. If this fails to manage your pain — as a general rule on 3 consecutive occasions — then you should try the next treatment.

• Step 1. Simple pain relief medicine alone

Most simple pain relief medicines are available to buy over-the-counter in pharmacies and supermarkets.

Many people who have migraines find that over-the-counter painkillers, such as acetaminophen (Tylenol), aspirin and ibuprofen (Advil, Advil-Migraine or Motrin IB), can help to reduce their symptoms.

They tend to be most effective if taken at the first signs of a migraine attack, as this gives them time to absorb into your bloodstream and ease your symptoms.

It’s not advisable to wait until the headache worsens before taking painkillers as it’s often too late for the medication to work. Soluble painkillers (tablets you dissolve in a glass of water) like Advil-Migraine are a good alternative because they’re absorbed quickly by your body.

If you can’t swallow painkillers because of nausea or vomiting, suppositories may be a better option. These are capsules that are inserted into the anus (back passage).

Take pain relief medicine at the first sign of migraine symptoms. As a migraine progresses, your stomach emptying can slow and this can affect the absorption of pain relievers into your bloodstream, making them less effective. This is especially important if you experience nausea and vomiting with migraine.

• Step 2. Simple pain reliever and medicine for nausea and vomiting

If nausea is a problem, or if a pain reliever alone does not relieve your migraine pain, you can take the pain reliever with medicine to treat nausea and vomiting.

Medication for nausea is usually combined with other medications. Frequently prescribed medications are chlorpromazine, metoclopramide (Reglan) or prochlorperazine (Compro).

• Step 3. Anti-migraine medicine: the triptans

If you find you can’t manage your migraines using over-the-counter medicines, your doctor may prescribe something stronger.

Triptans work differently to pain relievers. Triptan medicines are a specific painkiller for migraine headaches. There are a number of different triptans available in the US and you will need to get a prescription from your doctor.

Triptans are thought to work by reversing the changes in the brain that may cause migraine headaches.

They cause the blood vessels around the brain to contract (narrow). This reverses the dilating (widening) of blood vessels that’s believed to be part of the migraine process.

Triptans are available as tablets, injections and nasal sprays.

Common side effects of triptans include:

• warm-sensations
• tightness
• tingling
• flushing
• feelings of heaviness in the face, limbs or chest

Some people also experience nausea, dry mouth and drowsiness. These side effects are usually mild and improve on their own.

As with other painkillers, taking too many triptans can lead to medication overuse headache.

Your doctor will usually recommend having a follow-up appointment once you’ve finished your first course of treatment with triptans. This is so you can discuss their effectiveness and whether you had any side effects.

If the medication was helpful, treatment will usually be continued. If they weren’t effective or caused unpleasant side effects, your doctor may try prescribing a different type of triptan since responses can be highly variable.

• Step 4. Preventive therapy

If you are experiencing two or more severe migraine attacks a month, you could be a candidate for preventive therapy. Preventive therapy is used in addition to treatments for acute attack, not in place of it.

The aim of migraine preventive therapy is to reduce the number of attacks to a manageable level, either because:

• the medicines used to treat attacks don’t control your symptoms adequately, or
• migraine attacks, even though well controlled, are happening far too often, placing you at risk of developing medication overuse headache.

Note that it may take some months for the full effect of preventive therapy to be seen.

In general, medicines used as preventive therapy are more commonly prescribed for the treatment of other conditions (eg, high blood pressure or depression) but have unrelated anti-migraine effects — for example:

• beta-blockers — Propranolol (Deralin), atenolol (Noten, Anselol), metoprolol (Betaloc, Lopressor)
• amitriptyline (Endep).

Other medicines occasionally used to prevent migraines include antiepileptic medicines (especially sodium valproate [Epilim, Valpro] and topiramate [Epiramax, Tamate]), methysergide (Deseril) and botulinum toxin (botox).

Treatment can be complicated and is best managed by a specialist (neurologist).

Is Advil-Migraine better than acetaminophen or aspirin?

Advil-Migraine (ibuprofen), acetaminophen (paracetamol) and aspirin are all effective painkillers.

Advil-Migraine (ibuprofen) is good for period pain and migraines. It can also be used for back pain, strains and sprains, as well as pain from arthritis.

Acetaminophen (Tylenol) is typically used for mild or moderate pain. Acetaminophen (Tylenol, others), also may help relieve mild migraines in some people. It may be better than Advil-Migraine (ibuprofen) for headaches, toothache, sprains, stomach ache, and nerve pain like sciatica.

Aspirin works in a similar way to Advil-Migraine (ibuprofen). Like Advil-Migraine (ibuprofen), it’s good for period pain and migraines. (If you have heavy periods, it can make them heavier.)

How long will I take Advil-Migraine tablets for?

If you’re taking Advil-Migraine (ibuprofen) for a short-lived pain like migraine, you may only need to take it for a day or two.

If you need to take Advil-Migraine (ibuprofen) for more than 6 months, your doctor may prescribe a medicine to protect your stomach from any side effects.

Can I take Advil-Migraine for a long time?

It’s safe to take Advil-Migraine (ibuprofen) regularly for many years if you need to as long as you don’t take more than the recommended dosage.

If you need to take Advil-Migraine (ibuprofen) by mouth for a long time and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Does Advil-Migraine cause stomach ulcers?

Advil-Migraine (ibuprofen) can cause ulcers in your stomach or gut, especially if you take it by mouth for a long time or in big doses.

If you need to take Advil-Migraine (ibuprofen) and you’re at risk of getting a stomach ulcer, your doctor may prescribe a medicine to help protect your stomach.

Can I drink alcohol with Advil-Migraine?

It’s usually safe to drink alcohol while taking Advil-Migraine (ibuprofen). But if you’re taking Advil-Migraine (ibuprofen) by mouth, drinking too much alcohol may irritate your stomach and increases your risk of getting stomach ulcers.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking any type of Advil-Migraine (ibuprofen).

It’s best to take Advil-Migraine (ibuprofen) tablets, capsules or syrup with, or just after, a meal so it doesn’t upset your stomach. Don’t take it on an empty stomach.

What if Advil-Migraine doesn’t work?

If Advil-Migraine (ibuprofen) doesn’t work, there are other everyday painkillers you can try, such as:

• acetaminophen (paracetamol)
• aspirin
• co-codamol (acetaminophen combined with low-dose codeine). Opioid medications containing narcotics, particularly codeine, are sometimes used to treat migraine pain for people who can’t take triptans or ergots. Narcotics are habit-forming and are usually used only if no other treatments provide relief.

If pharmacy painkillers don’t work, your doctor may be able to prescribe a stronger painkiller or recommend another treatment, such as triptans or ergots.

Ergotamine and caffeine combination drugs (Migergot, Cafergot) are less effective than triptans. Ergots seem most effective in those whose pain lasts for more than 48 hours. Ergots are most effective when taken soon after migraine symptoms start.

Ergotamine may worsen nausea and vomiting related to your migraines, and it may also lead to medication-overuse headaches.

Dihydroergotamine (D.H.E. 45, Migranal) is an ergot derivative that is more effective and has fewer side effects than ergotamine. It’s also less likely to lead to medication-overuse headaches. It’s available as a nasal spray and in injection form.

Will Advil-Migraine affect my fertility?

Taking Advil-Migraine (ibuprofen) by mouth, in large doses, or for a long time can affect ovulation in women, possibly making it more difficult for you to get pregnant. This is usually reversible when you stop taking Advil-Migraine (ibuprofen).

Don’t take Advil-Migraine (ibuprofen) tablets, capsules or syrup if you’re trying for a baby. Acetaminophen (Paracetamol) is a better option.

Will Advil-Migraine affect my contraception?

Advil-Migraine (ibuprofen) – by mouth or on your skin – doesn’t affect any contraceptives, including the contraceptive pill and the morning after pill.

Advil-Migraine vs Excedrin Migraine

Advil-Migraine contains 200 mg ibuprofen a nonsteroidal anti-inflammatory drug (NSAID).

Excedrin-Migraine is a medicine that contains active ingredients in a combination of Acetaminophen (paracetamol), Aspirin, and Caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is acetylsalicylic acid in a group of drugs called salicylates, classified as a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. Caffeine relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin Migraine may also ease moderate migraine pain. But they aren’t effective alone for severe migraines. If taken too often or for long periods of time, these medications can lead to ulcers, gastrointestinal bleeding and medication-overuse headaches.

Pregnancy and breastfeeding

Advil-Migraine (ibuprofen) isn’t normally recommended in pregnancy.

It may cause birth defects affecting the baby’s heart or blood vessels. There may also be a link between taking Advil-Migraine (ibuprofen) in early pregnancy and miscarriage.

Acetaminophen (paracetamol) is the best painkiller to take during pregnancy.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

This medicine may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not use this medicine without a doctor’s advice if you are pregnant.

Use in late pregnancy should be avoided. May constrict ductus arteriosus in utero or inhibit or prolong labor as result of inhibition of prostaglandin synthetase ⁵.

For safety, tell your pharmacist or doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

To assess the fetal effects of exposure to ibuprofen overdose in pregnancy ⁶. Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) is a frequently used analgesic that is readily available over the counter. Concerns have been raised that therapeutic use of NSAIDs is associated with an increased risk of miscarriage and renal dysfunction. Although most acute overdoses are of low toxicity, few data exist on the potential fetotoxicity of ibuprofen overdose during pregnancy. Using standardized procedures, National Technical Information Service (NTIS) has provided fetal risk assessment and collected outcome data on a prospective case series of 100 women who took ibuprofen in overdose during pregnancy. Results are the majority of liveborn infants (66/73=90.4%) had no congenital anomalies. No pattern of anomalies was observed. Multidrug overdoses in which ibuprofen was the major constituent were taken by 68%, mainly compound analgesics and cold remedies with 28% taking paracetamol. The majority (86%) of overdoses occurred in the first trimester with only 9 (9%) reports of any significant maternal toxicity including 1 mother who was unconscious. Conclusion: The incidence of miscarriages (9% versus 10-20%) and terminations (18% versus 23%) is within the expected range ⁶. However, the incidence of congenital anomalies is higher (7/73=9.6% versus 2-3% expected), but two exposures were second trimester, and the numbers are small. Although no pattern of malformations was seen, three were cardiac anomalies ⁶. As congenital heart anomalies are common 0.5-1% it is not possible to establish a causal relationship with the drugs taken in overdose. No cases of renal dysfunction were seen. In the majority of women who receive appropriate treatment at the time of the overdose the outcome of pregnancy is a normal baby ⁶.

Advil-Migraine (ibuprofen) and breastfeeding

Advil-Migraine (ibuprofen) is safe to take by mouth if you are breastfeeding.

Two early studies attempted measurement of ibuprofen in milk ⁷, ⁸. In one, the patient’s dose was 400 mg twice daily, while in the second study of 12 patients, the dose was 400 mg every 6 hours. Ibuprofen was undetectable in breastmilk in both studies (<0.5 and 1 mg/L, respectively) ⁷, ⁸.

A later study using a more sensitive assay found ibuprofen in the breastmilk of one woman who took 6 doses of 400 mg orally over a 42.5 hours. A milk ibuprofen level of 13 mcg/L was detected 30 minutes after the first dose. The highest level measured was 180 mcg/L about 4 hours after the third dose, 20.5 hours after the first dose. The authors estimated that the infant would receive about 17 mcg/kg daily (100 mcg daily) with the maternal dose of approximately 1.2 grams daily. This dose represents 0.0008% of the maternal weight-adjusted dosage ⁹ and 0.06% of the commonly accepted infant dose of 30 mg/kg daily (10 mg/kg every 8 hours).

Single milk samples were taken from 13 women between 1.5 and 8 hours after the third dose of ibuprofen in a daily dosage regimen averaging 1012 mg daily (range 400 to 1200 mg daily). Of the 13 milk samples analyzed, the mean milk concentration was 361 mcg/L (range 164 to 590 mcg/L). The mean weight-adjusted percentage of the maternal dosage (relative infant dosage) was estimated to be <0.38%; however, the relative infant dosage varied with the time postpartum and the milk protein content. The relative infant dosage was highest in the colostral phase when the milk protein content was the highest (relative infant dosage 0.6%). The estimated mean dosage for a fully breastfed infants was 68 mcg/kg daily or 0.2% of a pediatric dosage ¹⁰.

What is Advil-Migraine (ibuprofen) used for?

Advil-Migraine (ibuprofen) can be used for the short-term relief of fever, mild to moderate pain and inflammation (redness, swelling and soreness).

Advil-Migraine (ibuprofen) might ease some of the symptoms of:

• headaches e.g. migraines or tension headache
• sinus pain
• toothache and pain after dental procedures
• backache, muscular aches and pains
• period pain/primary dysmenorrhea
• sore throat
• joint or tendon sprains and strains such as tennis elbow
• arthritis
• fever (pyrexia) or high temperature.
• Advil-Migraine (ibuprofen) is also indicated for the relief of acute and/or chronic pain states in which there is an inflammatory component. For example, Rheumatoid arthritis, Juvenile rheumatoid arthritis and Osteoarthritis

Please note that Advil-Migraine (ibuprofen) provides only temporary relief – it won’t cure your condition.

Advil-Migraine vs Ibuprofen

Advil-Migraine is a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID) – Ibuprofen.

Who can and can’t take Advil-Migraine

Some brands of Advil-Migraine (ibuprofen) tablets, capsules and syrup contain aspartame, colors (E numbers), gelatin, glucose, lactose, sodium, sorbitol, soya or sucrose, so they may be unsuitable for some people.

Don’t take Advil-Migraine (ibuprofen) by mouth if you:

• have had an allergic reaction to Advil-Migraine (ibuprofen) or any other medicines in the past
• have previously had a reaction, such as asthma, a raised, itchy red rash (urticaria), swelling underneath your skin (angioedema) or swelling of the inside of your nose (rhinitis)
• have taken aspirin or any other nonsteroidal anti-inflammatory drug (NSAID)
• have asthma or another allergic illness
• are trying to get pregnant, are already pregnant or if you’re breastfeeding

To make sure Advil-Migraine (ibuprofen) (by mouth) is safe for you, tell your doctor or pharmacist if you have:

• had bleeding in your stomach, a stomach ulcer, or a perforation (a hole) in your stomach
• a health problem that means you have an increased chance of bleeding
• liver problems, such as liver fibrosis, cirrhosis or liver failure
• heart disease or severe heart failure
• kidney failure
• Crohn’s disease or ulcerative colitis
• chickenpox or shingles – taking Advil-Migraine (ibuprofen) can increase the chance of certain infections and skin reactions

Cautions with other medicines

Advil-Migraine (ibuprofen) doesn’t mix well with some medicines.

Advil-Migraine (ibuprofen) applied to the skin is less likely to interfere with other medicines than if it’s taken by mouth.

For safety, tell your doctor if you’re taking these medicines before you start taking Advil-Migraine (ibuprofen) by mouth or on your skin:

• blood-thinning medicines such as warfarin
• anti-inflammatory painkillers such as aspirin, diclofenac, mefenamic acid and naproxen
• medicines for high blood pressure
• steroid medicines such as betamethasone, dexamethasone, hydrocortisone or prednisolone
• antibiotics such as ciprofloxacin, levofloxacin, moxifloxacin, nalidixic acid, norfloxacin or ofloxacin
• antidepressants such as citalopram, fluoxetine, fluvoxamine, venlafaxine, paroxetine or sertraline
• diabetes medicines such as gliclazide, glimepiride, glipizide and tolbutamide

Other uses for Advil-Migraine

Advil-Migraine (ibuprofen) is also sometimes used to treat ankylosing spondylitis (arthritis that mainly affects the spine), gouty arthritis (joint pain caused by a build-up of certain substances in the joints), and psoriatic arthritis (arthritis that occurs with a long-lasting skin disease that causes scaling and swelling). Talk to your doctor about the risks of using this drug for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Prescription Advil-Migraine (ibuprofen) comes as a tablet to take by mouth. It is usually taken three or four times a day for arthritis or every 4 to 6 hours as needed for pain. Nonprescription Advil-Migraine (ibuprofen) comes as a tablet, chewable tablet, suspension (liquid), and drops (concentrated liquid). Adults and children older than 12 years of age may usually take nonprescription Advil-Migraine (ibuprofen) every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription Advil-Migraine (ibuprofen) every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Advil-Migraine (ibuprofen) may be taken with food or milk to prevent stomach upset. If you are taking Advil-Migraine (ibuprofen) on a regular basis, you should take it at the same time(s) every day. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Advil-Migraine (ibuprofen) exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.

Advil-Migraine (ibuprofen) comes alone and in combination with other medications. Some of these combination products are available by prescription only, and some of these combination products are available without a prescription and are used to treat cough and cold symptoms and other conditions. If your doctor has prescribed a medication that contains Advil-Migraine (ibuprofen), you should be careful not to take any nonprescription medications that also contain Advil-Migraine (ibuprofen).

If you are selecting a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for you. Check nonprescription product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose. This is especially important if you will be giving cough and cold medications to a child.

Nonprescription cough and cold combination products, including products that contain Advil-Migraine (ibuprofen), can cause serious side effects or death in young children. Do not give these products to children younger than 4 years of age. If you give these products to children 4 to 11 years of age, use caution and follow the package directions carefully.

If you are giving Advil-Migraine (ibuprofen) or a combination product that contains Advil-Migraine (ibuprofen) to a child, read the package label carefully to be sure that it is the right product for a child of that age. Do not give Advil-Migraine (ibuprofen) products that are made for adults to children.

Before you give an Advil-Migraine (ibuprofen) product to a child, check the package label to find out how much medication the child should receive. Give the dose that matches the child’s age on the chart. Ask the child’s doctor if you don’t know how much medication to give the child.

Shake the suspension and drops well before each use to mix the medication evenly. Use the measuring cup provided to measure each dose of the suspension, and use the dosing device provided to measure each dose of the drops.

The chewable tablets may cause a burning feeling in the mouth or throat. Take the chewable tablets with food or water.

Stop taking nonprescription Advil-Migraine (ibuprofen) and call your doctor if your symptoms get worse, you develop new or unexpected symptoms, the part of your body that was painful becomes red or swollen, your pain lasts for more than 10 days, or your fever lasts more than 3 days. Stop giving nonprescription Advil-Migraine (ibuprofen) to your child and call your child’s doctor if your child does not start to feel better during the first 24 hours of treatment. Also stop giving nonprescription Advil-Migraine (ibuprofen) to your child and call your child’s doctor if your child develops new symptoms, including redness or swelling on the painful part of his body, or if your child’s pain or fever get worse or lasts longer than 3 days.

Do not give nonprescription Advil-Migraine (ibuprofen) to a child who has a sore throat that is severe or does not go away, or that comes along with fever, headache, nausea, or vomiting. Call the child’s doctor right away, because these symptoms may be signs of a more serious condition.

Before taking Advil-Migraine

• tell your doctor and pharmacist if you are allergic to Advil-Migraine (ibuprofen), aspirin or other NSAIDs such as ketoprofen and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in the type of Advil-Migraine (ibuprofen) you plan to take. Ask your pharmacist or check the label on the package for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexipril (Univasc), perindopril (Aceon, in Prestalia), quinapril (Accupril, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin receptor blockers such as candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); diuretics (‘water pills’); lithium (Lithobid); and methotrexate (Otrexup, Rasuvo, Trexall). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• do not take nonprescription Advil-Migraine (ibuprofen) with any other medication for pain unless your doctor tells you that you should.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the inside of the nose); heart failure; swelling of the hands, arms, feet, ankles, or lower legs; lupus (a condition in which the body attacks many of its own tissues and organs, often including the skin, joints, blood, and kidneys); or liver or kidney disease. If you are giving Advil-Migraine (ibuprofen) to a child, tell the child’s doctor if the child has not been drinking fluids or has lost a large amount of fluid from repeated vomiting or diarrhea.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy; you plan to become pregnant; or you are breast-feeding. If you become pregnant while taking Advil-Migraine (ibuprofen), call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Advil-Migraine (ibuprofen).
• if you have phenylketonuria (PKU, an inborn disease in which mental retardation develops if a specific diet is not followed), read the package label carefully before taking nonprescription Advil-Migraine (ibuprofen). Some types of nonprescription Advil-Migraine (ibuprofen) may be sweetened with aspartame, a source of phenylalanine.

Advil-Migraine dosage

A few reminders:

• When taking any medicine, always read and follow the label carefully.
• Always keep the outer carton of Advil-Migraine products.
• These ibuprofen dosage directions are for adults and children 12 years and older.
• Do not take more than directed.

How many Advil-Migraine can I take?

The usual dose for adults is two 200mg caplets a day. If this isn’t enough, your doctor may prescribe a higher dose of up to 600mg to take 4 times a day.

If you take Advil-Migraine (ibuprofen) 3 times a day, leave at least 6 hours between doses. If you take it 4 times a day, leave at least 4 hours between doses.

If you have pain all the time, your doctor may recommend slow-release Advil-Migraine (ibuprofen) tablets or capsules. It’s usual to take these once a day in the evening or twice a day. Leave a gap of 10 to 12 hours between doses if you’re taking Advil-Migraine (ibuprofen) twice a day.

For people who find it difficult to swallow tablets or capsules, Advil-Migraine (ibuprofen) is available as a tablet that melts in your mouth, granules that you mix with a glass of water to make a drink, and as a syrup.

Swallow Advil-Migraine (ibuprofen) tablets or capsules whole with a glass of water or milk. Don’t chew, break, crush or suck them as this could irritate your mouth or throat.

Always take Advil-Migraine (ibuprofen) tablets and capsules after a meal or snack or with a drink of milk. It will be less likely to upset your tummy.

What if I forget to take it?

Take the missed dose as soon as you remember, unless it’s almost time for your next dose. In this case, skip the missed dose and take your next dose as normal.

Never take a double dose to make up for a forgotten one.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Taking too much Advil-Migraine (ibuprofen) by mouth can be dangerous. It can cause side effects such as:

• feeling sick and vomiting
• tummy pain
• feeling tired or sleepy
• black poo and blood in your vomit – a sign of bleeding in your stomach
• tinnitus (ringing in your ears)
• difficulty breathing or changes in your heart rate (slower or faster)

If you need to go to hospital, take the ibuprofen packet or leaflet inside it plus any remaining medicine with you.

Advil-Migraine Tablets

Active Ingredient: Ibuprofen 200 mg in each tablet / caplets / gel caplets

Inactive Ingredients: D&C yellow no. 10, FD&C green no. 3, FD&C red no. 40, gelatin, light mineral oil, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Other information:

• read all warnings and directions before use. Keep carton.
• store at 20-25 °C (68-77 °F)
• avoid excessive heat above 40 °C (104 °F)

Advil-Migraine Uses

• Treats migraine

Dosing Information:

The smallest effective dose should be used

• Adults:
  • take 2 capsules with a glass of water
  • if symptoms persist of worsen, ask your doctor
  • do not take more than 2 capsules in 24 hours, unless directed by a doctor
• Under 18 years of age: Ask a doctor.

Advil-Migraine Warnings

Allergy alert

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

• hives
• facial
• swelling
• asthma (wheezing)
• shock
• skin reddening
• rash
• blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning

This product contains an nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Heart attack and stroke warning

Nonsteroidal anti-inflammatory drugs (NSAIDs), except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed

Do NOT use

• if you ever had an allergic reaction to any other pain reliever/fever reducer
• right before or after heart surgery

Ask a doctor before use if:

• stomach bleeding warning applies to you
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

• under a doctor’s care for any serious condition
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

Stop use and ask a doctor if:

• you experiences any of the following signs of stomach bleeding:
  • feel faint
  • vomits blood
  • has bloody or black stools
  • has stomach pain that does not get better
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• you do not get any relief within first day (24 hours) of treatment
• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present in the painful area
• any new symptoms appear

Advil-Migraine side effects

Common side effects

The common side effects of Advil-Migraine (ibuprofen) taken by mouth happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or don’t go away:

• headache
• feeling dizzy
• feeling sick or vomiting
• wind and indigestion
• upset stomach e.g. nausea, diarrhea and indigestion
• headache
• dizziness
• high blood pressure
• fluid retention.

There can be extra risks if you take Advil-Migraine (ibuprofen) when you are over 65, or have an ulcer, so discuss this with your doctor. Advil-Migraine (ibuprofen), like all NSAIDs, can also make heart disease worse – talk to your doctor before taking Advil-Migraine (ibuprofen) if you have any concerns.

Less common side effects include:

• feeling sleepy or anxious
• pins and needles
• problems with your eyesight
• hearing ringing in your ears
• difficulty falling asleep

Advil-Migraine (ibuprofen) tablets and capsules can cause inflammation of the stomach (gastritis) and ulcers in your stomach, gut or mouth. It can also make it difficult to breathe, or make asthma worse.

Serious side effects

Serious side effects of ibuprofen that need immediate medical attention include:

• black poo or blood in your vomit – these can be signs of bleeding in your stomach
• swollen ankles, blood in your pee or not peeing at all – these can be signs of a kidney problem
• severe chest or tummy pain – these can be signs of a hole in your stomach or gut
• difficulty breathing

This is not a full list of side effects. For more information, talk to your doctor or pharmacist. Or, if you’re experiencing a serious or life-threatening side effect, immediately call your local emergency number immediately.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Advil-Migraine (ibuprofen).

• A serious allergic reaction is an emergency. Call your local emergency number straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue, or throat

These are not all the side effects of Advil-Migraine (ibuprofen) tablets, capsules and syrup. For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• indigestion – stop taking Advil-Migraine (ibuprofen) and see your doctor as soon as possible. If you need something to ease the discomfort, try taking an antacid, but don’t put off going to the doctor.
• feeling sick – stick to simple meals. Don’t eat rich or spicy food
• vomiting – have small, frequent sips of water. It may also help to take oral rehydration solutions like Pedialyte you can buy from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat vomiting without speaking to a pharmacist or doctor.
• wind – try not to eat foods that cause wind (like pulses, lentils, beans and onions). Eat smaller meals, eat and drink slowly, and exercise regularly. There are pharmacy medicines that can also help, such as charcoal tablets or simethicone.
• your skin being sensitive to sunlight – stay out of bright sun and use a high factor sun cream (SPF 30 or above) even on cloudy days. Don’t use a sun lamp or sun beds.

Human Toxicity Reports

Gastrointestinal side effects are experienced by 5-15% of patients taking ibuprofen; epigastric pain, nausea, heartburn and sensations of “fullness” in the gastrointestinal tract are the usual difficulties ¹¹. However, the incidence of theses side effects is less with ibuprofen than with aspirin or indomethacin. Other side effects of ibuprofen have been reported less frequently. They include thrombocytopenia, skin rashes, headache, dizziness and blurred vision and in a few cases, toxic amblyopia, fluid retention and edema ¹¹.

Fatal autoimmune hemolytic anemai occurred coincident with oral administration of ibuprofen 400 mg 3 times per day in 49 yr old male ¹².

Healthy subjects treated for 2 weeks with 3 times daily ibuprofen showed a total blood loss of 9.7 ml. Mean daily blood loss was significantly higher than on placebo ¹³.

In ibuprofen overdose cases, the majority of patients had no symptoms or only mild symptoms such as nausea or vomiting. Lab analyses available for some cases demonstrate that plasma ibuprofen concentrations of up to 704 mg/L could be associated with no symptoms ¹⁴.

A case of aseptic meningoencephalitis induced by ibuprofen (Brufen) is decribed in a 24 year old unmarried woman with unrecognized systemic lupus erythematosus. The neurological manifestations induced by ibuprofen revealed the systemic disease. Clinicians confronted with aseptic meningitis or meningoencephalitis developed after treatment with a non-steroidal anti-inflammatory drug, notably ibuprofen, should investigate for systemic disease ¹⁵.

Ibuprofen (Motrin, Brufen) an anti inflammatory phenylpropionic derivative, was reported in 1971 to have caused reversible centrocecal field defects and reduced visual acuity in two patients, and a reversible “moving mosaic of colored lights in front of both eyes” in another ¹⁶. One patient was reported to have a drastic impairment of color vision & decr in visual acuity, which were largely reversible on discontinuing ibuprofen. Another patient on 2 occasions after taking ibuprofen has complained of seeing streaks shooting from lateral to central field of vision; eye exams were normal ¹⁶. Cortical visual evoked potentials were evaluated in a patient who had 20/50, 20/60 vision with decreased brightness of colors after taking ibuprofen for 2 months, showing decreased amplitudes & increased conduction times, but these became normal 6 days after the drug was stopped; vision became normal later ¹⁶.

In a series of 293 patients treated during a five year period no visual symptoms were detected that were thought attributable to the drug ¹⁶ and in another series of 247 patients there was no evidence of toxic amblyopia or maculopathy attributable to ibuprofen. A prospective study in 1975 reported no evidence of eye toxicity in 45 healthy volunteers treated for 3 months, or in 78 patients with osteoarthritis during 6 months ¹⁶.

Chemically induced renal dysfunction caused by ibuprofen is dose/duration related ¹⁷. Most common presentation renal insufficiency that can lead to acute or chronic renal failure. Cell-mediated nephrotic syndrome can occur. Short term use of moderate dose ibuprofen may result in /acute renal failure/ in patients with asymptomatic mild chronic renal failure.

Prostaglandins are known to be involved in the metabolism of bone, having a significant influence on bone resorption in cases of bone pathology ¹⁸. This study ¹⁸ investigated the short-term effects of two commonly used nonsteroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen (paracetamol), on bone resorption in healthy men. In a randomized, double-blind pilot study, 28 healthy, age- and weight-matched male volunteers were treated with ibuprofen (n = 10), acetaminophen (n = 9), or a placebo (n = 9) for 3 days. As an indication of bone resorption rate, levels of the biochemical bone markers N-telopeptide (NTx) and free deoxypyridinoline (D-Pyr) were measured in urine. Differences in resorption marker levels pre- and post-NSAID use were then compared between groups. The study authors ¹⁸ found that NTx concentrations in the acetaminophen group were lower than placebo, whereas NTx levels in the ibuprofen group were higher than in the acetaminophen group. By contrast, D-Pyr concentrations in the ibuprofen group were significantly lower than in the placebo group (p = 0.009). A comparison of the percentage changes of D-Pyr:NTx ratios found that the ratio in the ibuprofen group was significantly lower than that of both the control and acetaminophen groups. These results show the differential effects of ibuprofen and acetaminophen on urinary excretion of peptide-bound and free deoxypyridinoline cross-links of type I collagen. Short-term ibuprofen use may alter the renal handling of collagen cross-links and increase bone resorption to a greater extent than acetaminophen in normal men ¹⁸.

Advil-Migraine overdose

Can you overdose on Advil-Migraine? Yes

In case of Advil-Migraine overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call your local emergency services number.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

Symptoms of Advil-Migraine overdosage may include:

• dizziness
• fast eye movements that you cannot control
• slow breathing or short periods of time without breathing
• blue color around the lips, mouth, and nose

Symptoms may develop in the following areas:

Eyes, ears, nose, throat, and mouth:

• Ringing in the ears
• Blurred vision

Gastrointestinal:

• Diarrhea
• Heartburn
• Nausea, vomiting (sometimes bloody)
• Stomach pain (possible bleeding in stomach and intestines)

Heart and blood:

• Low blood pressure (shock) and weakness

Kidneys:

• Little to no urine production

Lungs:

• Breathing — difficult
• Breathing — slow
• Wheezing

Nervous system:

• Agitation, confusion, incoherent (not understandable)
• Drowsiness, even coma
• Convulsions
• Dizziness
• Headache (severe)
• Unsteadiness, trouble moving

Skin:

• Rash
• Sweating

Other:

• Chills

What to Expect at the Emergency Room

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure. Symptoms will be treated as appropriate. The person may receive:

• Activated charcoal
• Airway support, including oxygen, breathing tube through the mouth (intubation), and breathing machine (ventilator)
• Blood and urine tests
• Chest x-ray
• Tube through the mouth into the stomach and small intestine to identify and treat internal bleeding (endoscopy)
• EKG (electrocardiogram, or heart tracing)
• Fluids through a vein (intravenous or IV)
• Laxative
• Medicines to treat symptoms

Outlook (Prognosis)

Recovery is likely with prompt medical treatment, except in very large overdoses. Some people may develop chronic liver or kidney injury.

1. White WB, Kloner RA, Angiolillo DJ, Davidson MH. Cardiorenal Safety of OTC Analgesics. Journal of Cardiovascular Pharmacology and Therapeutics. 2018;23(2):103-118. doi:10.1177/1074248417751070. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808827/
2. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti-inflammatory drugs. J Pain Res. 2015;8:105–118 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346004/
3. FitzGerald GA. COX-2 and beyond: approaches to prostaglandin inhibition in human disease. Nat Rev Drug Discov. 2003;2(11):879–890 https://www.nature.com/articles/nrd1225
4. Brune K, Patrignani P. New insights into the use of currently available non-steroidal anti-inflammatory drugs. Journal of Pain Research. 2015;8:105-118. doi:10.2147/JPR.S75160. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346004/
5. Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103; 1990
6. J Toxicol Clin Toxicol 2003;41(4):551-2
7. Weibert RT, Townsend RJ, Kaiser DG et al. Lack of ibuprofen secretion into human milk. Clin Pharm. 1982;1:457-8 https://www.ncbi.nlm.nih.gov/pubmed/7184678
8. Townsend RJ, Benedetti TJ, Erickson SH et al. Excretion of ibuprofen into breast milk. Am J Obstet Gynecol. 1984;149:184-6 https://www.ajog.org/article/0002-9378(84)90195-9/pdf
9. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol. 1997;44:211-2
10. Rigourd V, de Villepin B, Amirouche A et al. Ibuprofen concentrations in human mature milk-First data about pharmacokinetics study in breast milk with AOR-10127 “Antalait” study. Ther Drug Monit. 2014;36:590-6 https://www.ncbi.nlm.nih.gov/pubmed/24695355
11. Hardman, J.G., L.E. Limbird, P.B. Molinoff, R.W. Ruddon, A.G. Goodman (eds.). Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 9th ed. New York, NY: McGraw-Hill, 1996., p. 712
12. GUIDRY JB ET AL; JAMA 242 (JUL 6): 68; 1979 https://jamanetwork.com/journals/jama/article-abstract/365628
13. WARRINGTON SJ ET AL; RHEUMATOLOGY 7 (NEW TRENDS OSTEOARTHRITIS): 107;1982
14. COURT H ET AL; HUM TOXICOL 2 (2): 381; 1983 https://www.ncbi.nlm.nih.gov/pubmed/6862484
15. Lortholary A et al; Rev Med Interne 11 (3): 243-4; 1990 https://www.ncbi.nlm.nih.gov/pubmed/2096424
16. Grant, W.M. Toxicology of the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986., p. 506
17. Young, L.Y., M.A. Koda-Kimble (eds.). Applied Therapeutics. The Clinical Use of Drugs. 6th ed. Vancouver, WA., Applied Therapeutics, Inc. 1995., p. 29-12
18. Head JE et al; Bone 29 (5): 437-41; 2001 https://www.ncbi.nlm.nih.gov/pubmed/11704495

What is Cold Eeze

Cold-Eeze lozenges contain the active ingredient (per lozenge): Zincum Gluconicum 2X (13.3mg Zinc). Cold-Eeze lozenges is used to reduce the duration of the common cold and reduce the severity of cold symptoms: cough, sore throat, stuffy nose, sneezing, post nasal drip and/or hoarseness.

Cold-Eeze lozenges inactive Ingredients: Corn syrup, glycine, natural flavors and sucrose. No artificial colors or preservatives.

Zinc is a trace metal with in test tube activity against rhinovirus, the major etiologic agent in acute upper respiratory tract infections ¹, ².

Cold Eeze Warnings

Ask a doctor before use if you are taking minocycline, doxycycline, tetracycline or are on coumadin therapy, zinc treatment may inhibit the absorption of these medicines

Stop use and ask your healthcare practitioner if symptoms persist beyond 7 days.

Cold-Eeze lozenges are formulated to reduce the duration of the common cold and its symptoms and is insufficient treatment for Influenza or Allergies.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

Does Cold Eeze work?

The common cold is often caused by the rhinovirus. It is one of the most widespread illnesses and is a leading cause of visits to the doctor and absenteeism from school and work. Complications of the common cold include otitis media (middle ear infection), sinusitis and exacerbations of reactive airway diseases ³. There is no proven treatment for the common cold ³. However, a medication that is even partially effective in the treatment and prevention of the common cold could markedly reduce morbidity and economic losses due to this illness.

Zinc, which can inhibit rhinovirus replication in test tube studies and has activity against other respiratory viruses such as respiratory syncytial virus ¹. The exact mechanism of zinc’s activity on viruses remains uncertain. Zinc may also reduce the severity of cold symptoms by acting as an astringent on the trigeminal nerve ⁴.

There’s been a lot of talk about taking zinc for colds ever since a 1984 study ⁵ showed that zinc supplements kept people from getting as sick. Since then, research has turned up mixed results about zinc and colds – failure of zinc gluconate in treatment of acute upper respiratory tract infections ⁶, ⁷, ⁸ and a positive result for zinc in the treatment for common colds ⁹, ¹⁰, ¹¹, ¹².

Recently analyses of several studies ¹³, ¹⁴, ¹⁵ showed that zinc lozenges or syrup reduced the length of a cold by one day, especially when taken within 24 hours of the first signs and symptoms of a cold. In a 2015 meta-analysis by Hemilä and Chalker ¹³ showed that zinc acetate lozenges shortened the duration of nasal discharge by 34%, nasal congestion by 37% , sneezing by 22%, scratchy throat by 33%, sore throat by 18%, hoarseness by 43% and cough by 46%. Zinc lozenges shortened the duration of muscle ache by 54%, but there was no difference in the duration of headache and fever ¹³. The same authors concluded that the effect of zinc acetate lozenges on cold symptoms may be associated with the local availability of zinc from the lozenges, with the levels being highest in the pharyngeal region ¹³. However their findings indicate that the effects of zinc ions are not limited to the pharyngeal region. There is no indication that the effect of zinc lozenges on nasal symptoms is less than the effect on the symptoms of the pharyngeal region, which is more exposed to released zinc ions. In some zinc lozenge trials the lozenges caused short-term adverse effects, such as bad taste, nausea, constipation, diarrhea, abdominal pain, dry mouth and oral irritation, but the bad taste can be explained by the specific lozenge composition and does not necessarily reflect the effects of zinc ions themselves ¹⁶. None of the high dose zinc acetate lozenge trials reported bad taste to be a problem and there was no substantial difference between the zinc and placebo groups in the recorded adverse effects, and only a few drop-outs occurred ¹³. Furthermore, if a common cold patient suffers from acute adverse effects such as bad taste, the patient can simply stop taking the zinc acetate lozenges. Given that the adverse effects of zinc in the 3 trials were minor, zinc acetate lozenges releasing zinc ions at doses of about 80 mg/day may be a useful treatment for the common cold, started within 24 hours, for a time period of less than two weeks ¹³.

In the USA, the recommended dietary zinc intake is 11 mg/day for men and 8 mg/day for women ¹⁷. Thus, the 80 to 92 mg/day doses used in the zinc acetate lozenge trials are substantially higher than the recommended daily intakes. However, in several clinical trials zinc has been administered to patients at a dose of 150 mg/day for months ¹⁸. A decrease in copper levels and hematological changes have been reported as adverse effects of long-term high dose zinc administration, but those changes were completely reversed with the cessation of zinc intake ¹⁹, ²⁰, ²¹, ²². Thus, given that 150 mg/day of zinc administration for months does not cause permanent harm, it seems plausible that the use of about 80 mg/day of zinc for up to two weeks in the form of zinc acetate lozenges is unlikely to cause serious adverse effects.

But the recent analysis stopped short of recommending zinc. None of the studies analyzed had enough participants to meet a high standard of proof. Also, the studies used different zinc dosages and preparations (lozenges or syrup) for different lengths of time. As a result, it’s not clear what the effective dose and treatment schedule would be.

Most colds are caused by a type of virus called rhinovirus, which thrives and multiplies in the nasal passages and throat (upper respiratory system). Zinc may work by preventing the rhinovirus from multiplying. It may also stop the rhinovirus from lodging in the mucous membranes of the throat and nose.

Zinc may be more effective when taken in lozenge or syrup form, which allows the substance to stay in the throat and come in contact with the rhinovirus.

Zinc — especially in lozenge form — also has side effects, including nausea or a bad taste in the mouth. Many people who used zinc nasal sprays suffered a permanent loss of smell. For this reason, Mayo Clinic doctors caution against using such sprays.

In addition, large amounts of zinc are toxic and can cause copper deficiency, anemia and damage to the nervous system.

For now, the safest course is to talk to your doctor before considering the use of zinc to prevent or reduce the length of colds.

Cold Eeze vs Zicam

Zicam is nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Zicam is also used to relieve sinus congestion and pressure. Zicam active ingredient is called Oxymetazoline hydrochloride. Zicam (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Zicam (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Zicam nasal spray does not contain any zinc. Zicam (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Zicam (Oxymetazoline) nasal spray carefully and under adult supervision.

Zicam (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Zicam (Oxymetazoline) is available without a prescription.

Zicam Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes

Zicam (Oxymetazoline) is available in the following dosage forms:

• Nasal Solution
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use pump:

• to open, hold the actuator to squeeze and turn cap
• hold with thumb at bottom of bottle and nozzle between fingers
• before using the first time, prime pump by depressing several times
• place tip of nozzle just past nasal opening (approximately 1/8″)
• pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
• wipe nozzle clean after use
• to close, turn cap until it ‘clicks’

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Cold-Eeze directions

• Do NOT take Cold-Eeze lozenges on an empty stomach to avoid possible minor stomach upset. Avoid taking Cold-Eeze lozenges with foods that are high in calcium or phosphorus, which can make it harder for your body to absorb zinc gluconate. Foods high in calcium or phosphorus include milk, cheese, yogurt, ice cream, dried beans or peas, lentils, nuts, peanut butter, beer, cola soft drinks, and hot cocoa.
• Do NOT eat or drink for 15 minutes after use.
• store in a cool, dry place after opening
• gluten-free

Cold-Eeze dosage

• Adults and children 12 years and over:
  • take Cold-Eeze when you have cold symptoms
  • completely dissolve a Cold-Eeze lozenge in mouth (do not chew)
  • repeat every 2-4 hours as needed until all symptoms subside
  • recommended daily dosage is 6 lozenges for adults and 4 lozenges for ages 12-17
• Children under 12 years of age should consult a health professional prior to use

Cold Eeze side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get emergency medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect.

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives;
• rash;
• red, swollen, blistered, or peeling skin with or without fever;
• wheezing;
• tightness in the chest or throat;
• trouble breathing, swallowing, or talking; unusual hoarseness;
• swelling of the mouth, face, lips, tongue, or throat.

Less serious side effects may include:

• nausea; or
• upset stomach.

High zinc intakes can inhibit copper absorption, sometimes producing copper deficiency and associated anemia ²³, ²⁴. For this reason, dietary supplement formulations containing high levels of zinc, such as the one used in the Age-Related Eye Disease Study Research Group (AREDS) study ²⁵, sometimes contain copper.

Endocrine

Endocrine side effects have included the reduction of high density lipoprotein (HDL) “good cholesterol” in males.

Due to an accompanying decrease in low density lipoproteins (LDL), the LDL/HDL ratio remains relatively unchanged and little risk is assumed in terms of coronary heart disease. Triglyceride levels have not been shown to be affected.

Gastrointestinal

Gastrointestinal irritation appears to be dose-related.

Gastrointestinal side effects have included an unpleasant taste (80%), nausea (20%), mouth irritation (24%), dry mouth (12%), gastrointestinal upset (10%), distortion of taste, abdominal pain, vomiting, and diarrhea.

Nervous system

Nervous system side effects have rarely included dizziness and headache.

1. Suara RO, Crowe JE., Jr Effect of zinc salts on respiratory syncytial virus replication. Antimicrob Agents Chemother 2004;48: 783–90 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC353050/
2. Gwaltney, J. M., Jr. 1979. The common cold, p. 429-435. In G. L. Mandell, R. G. Douglas, and J. E. Bennett (ed.), Principles and practice of infectious diseases. John Wiley & Sons, Inc., New York.
3. Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD001364. DOI: 10.1002/14651858.CD001364.pub3 http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD001364.pub3/full
4. Novick SG, Godfrey JC, Godfrey NJ, et al. How does zinc modify the common cold? Clinical observations and implications regarding mechanisms of action. Med Hypotheses 1996;46:295–302 https://www.ncbi.nlm.nih.gov/pubmed/8676770
5. Couch RB. The common cold control?. Journal of Infectious Diseases 1984;150:167-73. https://www.ncbi.nlm.nih.gov/pubmed/6206168
6. Smith DS, Helzner EC, Nuttall CE, et al. Failure of zinc gluconate in treatment of acute upper respiratory tract infections. Antimicrobial Agents and Chemotherapy. 1989;33(5):646-648. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC172506/pdf/aac00073-0070.pdf
7. Farr BM, Conner EM, Betts RF, Oleske J, Minnefor A, Gwaltney JM. Two randomized controlled trials of zinc gluconate lozenge therapy of experimentally induced rhinovirus colds. Antimicrobial Agents and Chemotherapy. 1987;31(8):1183-1187. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC174900/pdf/aac00098-0045.pdf
8. Douglas RM, Miles HB, Moore BW, Ryan P, Pinnock CB. Failure of effervescent zinc acetate lozenges to alter the course of upper respiratory tract infections in Australian adults. Antimicrobial Agents and Chemotherapy. 1987;31(8):1263-1265. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC174915/pdf/aac00098-0125.pdf
9. Prophylaxis and treatment of rhinovirus colds with zinc gluconate lozenges. J Antimicrob Chemother. 1987 Dec;20(6):893-901. https://www.ncbi.nlm.nih.gov/pubmed/3440773
10. Zinc gluconate lozenges for treating the common cold. A randomized, double-blind, placebo-controlled study. Ann Intern Med. 1996 Jul 15;125(2):81-8. http://annals.org/aim/article-abstract/709805/zinc-gluconate-lozenges-treating-common-cold-randomized-double-blind-placebo?volume=125&issue=2&page=81
11. Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial. Duration of symptoms and plasma cytokine levels in patients with the common cold treated with zinc acetate. A randomized, double-blind, placebo-controlled trial. http://annals.org/aim/fullarticle/713796/zinc-acetate-lozenges-treat-common-cold
12. Zinc gluconate lozenges for common cold. A double-blind clinical trial. Dan Med Bull. 1990 Jun;37(3):279-81. https://www.ncbi.nlm.nih.gov/pubmed/2192839/
13. Hemilä H, Chalker E. The effectiveness of high dose zinc acetate lozenges on various common cold symptoms: a meta-analysis. BMC Family Practice. 2015;16:24. doi:10.1186/s12875-015-0237-6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4359576/
14. Science M, Johnstone J, Roth DE, Guyatt G, Loeb M. Zinc for the treatment of the common cold: a systematic review and meta-analysis of randomized controlled trials. CMAJ : Canadian Medical Association Journal. 2012;184(10):E551-E561. doi:10.1503/cmaj.111990. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3394849/
15. Singh M, Das RR. Zinc for the common cold. Cochrane Database of Systematic Reviews 2011, Issue 2. Art. No.: CD001364. DOI: 10.1002/14651858.CD001364.pub3. http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD001364.pub3/full
16. Zinc lozenges: cold cure or candy? Solution chemistry determinations. Eby GA. Biosci Rep. 2004 Feb; 24(1):23-39. https://www.ncbi.nlm.nih.gov/pubmed/15499830/
17. National Research Council . Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc. Washington, DC: The National Academies Press; 2001. p. 475.
18. Randomized, double-blind trial of 220 mg zinc sulfate twice daily in the treatment of rosacea. Bamford JT, Gessert CE, Haller IV, Kruger K, Johnson BP. Int J Dermatol. 2012 Apr; 51(4):459-62. https://www.ncbi.nlm.nih.gov/pubmed/22435439/
19. Samman S, Roberts DC. The effect of zinc supplements on plasma zinc and copper levels and the reported symptoms in healthy volunteers. Med J Aust. 1987;146:246–9. https://www.ncbi.nlm.nih.gov/pubmed/3547053
20. Prasad AS, Brewer GJ, Schoomaker EB, Rabbani P. Hypocupremia induced by zinc therapy in adults. JAMA. 1978;240:2166–8. doi: 10.1001/jama.1978.03290200044019 https://www.ncbi.nlm.nih.gov/pubmed/359844
21. Hoffman HN, Phyliky RL, Fleming CR. Zinc-induced copper deficiency. Gastroenterology. 1988;94:508–12 https://www.ncbi.nlm.nih.gov/pubmed/3335323
22. Forman WB, Sheehan D, Cappelli S, Coffman B. Zinc abuse: an unsuspected cause of sideroblastic anemia. West J Med. 1990;152:190–2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1002314/pdf/westjmed00114-0084.pdf
23. Broun ER, Greist A, Tricot G, Hoffman R. Excessive zinc ingestion. A reversible cause of sideroblastic anemia and bone marrow depression. JAMA 1990;264:1441-3. https://www.ncbi.nlm.nih.gov/pubmed/2094240?dopt=Abstract
24. Willis MS, Monaghan SA, Miller ML, McKenna RW, Perkins WD, Levinson BS, et al. Zinc-induced copper deficiency: a report of three cases initially recognized on bone marrow examination. Am J Clin Pathol 2005;123:125-31. https://www.ncbi.nlm.nih.gov/pubmed/15762288?dopt=Abstract
25. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol 2001;119:1417-36. https://www.ncbi.nlm.nih.gov/pubmed/11594942?dopt=Abstract

What is Emetrol

Emetrol is a phosphorated carbohydrate (sugar) solution used for the relief of upset stomach associated with nausea due to overindulgence in food and drink. Emetrol active ingredients in each 5 mL are: 1.87 g Dextrose (glucose) + 1.87 g Levulose (fructose) + 21.5 mg Phosphoric acid

Inactive ingredients: FD&C red no. 40, flavors, glycerin, methylparaben, and purified water.

Emetrol Warnings

This product contains fructose and should not be taken by persons with hereditary fructose intolerance.

Do not use if you have:

• allergic reactions to any of the ingredients in this product

Ask a doctor before use if you have:

• diabetes

Stop use and ask a doctor if:

• symptoms persist, return or get worse

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

How does Emetrol work

Glucose is a simple sugar (monosaccharide) that is a primary source of energy for living organisms. Glucose is naturally occurring and is found in fruits and other parts of plants in its free state. Glucose is used therapeutically in fluid and nutrient replacement. In your body glucose arises from the breakdown of glycogen in a process known as glycogenolysis. Glucose is synthesized in the liver and kidneys from non-carbohydrate intermediates, such as pyruvate and glycerol, by a process known as gluconeogenesis.

Fructose is a simple sugar (monosaccharide) found in sweet fruits and honey that is soluble in water, alcohol, or ether. Fructose is used as a preservative and an intravenous infusion in parenteral feeding.

Phosphoric Acid is a colorless, odorless phosphorus-containing inorganic acid. Phosphoric acid is a sequestering agent which binds many divalent cations, including Fe++, Cu++, Ca++, and Mg++. Phosphoric acid is used in dentistry and orthodontics as an etching solution, to clean and roughen the surfaces of teeth where dental appliances or fillings will be placed. In addition, phosphoric acid is a constituent in bone and teeth, and plays a role in many metabolic processes.

What do I need to tell my doctor BEFORE I take Emetrol?

• If you have an allergy to fructose, dextrose, phosphoric acid, or any other part of Emetrol (fructose, dextrose, and phosphoric acid).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are not able to break down fructose.

This is not a list of all drugs or health problems that interact with Emetrol (fructose, dextrose, and phosphoric acid).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Emetrol (fructose, dextrose, and phosphoric acid) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Emetrol?

• Tell all of your health care providers that you take Emetrol (fructose, dextrose, and phosphoric acid). This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Different brands of Emetrol (fructose, dextrose, and phosphoric acid) may be for use in different ages of children. Talk with the doctor before giving Emetrol (fructose, dextrose, and phosphoric acid) to a child.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Emetrol (fructose, dextrose, and phosphoric acid) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Is Emetrol safe for pregnancy?

There is no research data regarding the safety of Emetrol (fructose, dextrose, and phosphoric acid) for use during pregnancy or while pregnant or to treat early pregnancy morning sickness. If you’re pregnant or breast-feeding, you should consult with your doctor before using Emetrol. Furthermore, Emetrol (fructose, dextrose, and phosphoric acid) has not been found by the U.S. Food and Drug Administration (FDA) to be safe and effective, and their labeling has not been approved by FDA. For further information about unapproved drugs, please visit the FDA’s Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval, here https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm.

How is Emetrol best taken?

Use Emetrol (fructose, dextrose, and phosphoric acid) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Measure liquid doses carefully. Use the measuring device that comes with Emetrol (fructose, dextrose, and phosphoric acid). If there is none, ask the pharmacist for a device to measure Emetrol (fructose, dextrose, and phosphoric acid).
• Do not mix with any liquid.
• Do not drink any other liquids right before or after taking Emetrol (fructose, dextrose, and phosphoric acid).

Emetrol dosage

• for maximum effectiveness never dilute or drink fluids of any kind immediately before or after taking Emetrol (fructose, dextrose, and phosphoric acid)
• Adults and children 12 years of age and over: one to two tablespoons (15 ml to 30 ml)
• Children 2 to under 12 years of age: one or two teaspoons (5 ml to 10 ml)
• repeat dose every 15 minutes or until distress subsides
• do not take more than 5 doses in 1 hour without consulting a doctor
• measure only with dosing cup provided. Dosing cup to be used with Emetrol only. Do not use with other products.

Other information

• Store between 20-25ºC (68-77ºF) away from heat and direct light; keep from freezing
• Do not use if printed foil seal under bottle cap is broken or missing

What do I do if I miss a dose?

• Emetrol (fructose, dextrose, and phosphoric acid) is taken on an as needed basis. Do not take more often than told by the doctor.
• Do not take more than 5 doses in 1 hour unless told to do so by your doctor.

Emetrol side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Along with its needed effects, phosphorated carbohydrate solution (the active ingredient contained in Emetrol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking phosphorated carbohydrate solution and get emergency help immediately if any of the following effects occur:

Signs of fructose intolerance

• fainting
• swelling of face, arms, and legs
• unusual bleeding
• vomiting
• weight loss
• yellow eyes or skin

Some side effects of phosphorated carbohydrate solution may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common – more common with large doses

• diarrhea
• stomach or abdominal pain

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reactions are:

• rash;
• hives;
• itching; red, swollen, blistered, or peeling skin with or without fever;
• wheezing;
• tightness in the chest or throat;
• trouble breathing, swallowing, or talking;
• unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

If OVERDOSE is suspected:

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. Be ready to tell or show what was taken, how much, and when it happened.

This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. You can call 24 hours a day, 7 days a week.

What is Cepacol

Cepacol is a brand that has many different products. For example, there are Cepacol Sore Throat Lozenges and Cepacol Mouthwash.

Cepacol Sore Throat and Cough Mixed Berry Lozenges

Active Ingredients (in each lozenge): Benzocaine 7.5 mg [local anesthetic] + Dextromethorphan hydrobromide 5 mg [cough suppressant]

Inactive ingredients: FD&C blue no. 1, FD&C red no. 40, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Uses: Temporarily relieves:

• cough due to minor throat and bronchial irritation as may occur with the common cold
• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever and cough suppressant

Cepacol Sore Throat and Cough Mixed Berry Lozenges Dosage

• Adults and Children 12 years or older: take 2 lozenges (one immediately after the other) and allow each lozenge to dissolve slowly in the mouth; may be repeated every 4 hours, not to exceed 12 lozenges in any 24-hour period, or as directed by a doctor
• Children under 6 years of age: DO NOT USE

Cepacol Extra Strength Sore Throat Cherry Lozenges

Active Ingredients (in each lozenge): Benzocaine 15 mg [local anesthetic] + Menthol 3.6 mg [cooling sensation]

Inactive ingredients: D&C red no. 33, FD&C red no. 40, flavors, isomalt, maltitol, purified water, sodium bicarbonate, sucralose

Uses: Temporary relief of occasional:

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever

Cepacol Extra Strength Sore Throat Cherry Lozenges Dosage

• Adults and Children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• Children under 5 years of age: DO NOT USE

Cepacol Extra Strength Sore Throat Tangerine Lozenges

Active Ingredients (in each lozenge): Benzocaine 15 mg [local anesthetic] + Menthol 2.3 mg [cooling sensation]

Inactive ingredients: FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Uses: Temporary relief of occasional:

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever

Cepacol Extra Strength Sore Throat Tangerine Lozenges Dosage

• Adults and Children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• Children under 5 years of age: DO NOT USE

Cepacol Extra Strength Sore Throat Honey Lemon Lozenges

Active Ingredients (in each lozenge): Benzocaine 15 mg [local anesthetic] + Menthol 2.5 mg [cooling sensation]

Inactive ingredients: D&C yellow no. 10, FD&C yellow no. 6, flavors, isomalt, maltitol, propylene glycol, purified water, sodium bicarbonate, sucralose

Uses: Temporary relief of occasional:

• sore throat
• sore mouth
• minor mouth irritation
• pain associated with canker sores

Purpose: Oral pain reliever

Cepacol Extra Strength Sore Throat Honey Lemon Lozenges Dosage

• Adults and Children 5 years or older: allow lozenge to dissolve slowly in the mouth; may be repeated every 2 hours as needed or as directed by a doctor or dentist.
• Children under 5 years of age: DO NOT USE

Cepacol Mouthwash

Active Ingredients: Cetylpyridinium chloride 0.05%

Inactive ingredients: purified water, alcohol 14% v/v, glycerin, sodium phosphate dibasic, eucalyptus oil, polysorbate 80, methyl salicylate, cinnamon oil, peppermint oil, saccharin sodium, sodium phosphate monobasic anhydrous, menthol, edetate disodium, FD&C Yellow #5

Uses: Helps prevent and reduce plaque that leads to:

• gingivitis, an early form of gum disease
• bleeding gums

Purpose: Antigingivitis/Antiplaque

Cepacol Mouthwash Warnings

Stop use and ask a dentist if:

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of the reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Cepacol Mouthwash Directions of Use

• This rinse is not intended to replace brushing or flossing
• Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse
• Children 6 years to under 12 years of age: Supervise use
• Children under 6 years of age: DO NOT USE

What is Dextromethorphan?

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Dextromethorphan is used to treat a cough.

Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Dextromethorphan Important information

Do not give dextromethorphan to a child younger than 4 years old.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use dextromethorphan if you have used an monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dextromethorphan before the monoamine oxidase inhibitor (MAOI) has cleared from your body.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan. Dextromethorphan will not treat a cough that is caused by smoking, asthma, or emphysema.

Before taking Dextromethorphan

Do not use dextromethorphan if you have used an monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dextromethorphan before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist about using dextromethorphan if you have emphysema or chronic bronchitis.

Dextromethorphan may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Dextromethorphan may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cough medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

What should I avoid?

Avoid drinking alcohol. It can increase some of the side effects of dextromethorphan. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with cough medicine can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cough, cold, or allergy medication without first asking your doctor or pharmacist. Dextromethorphan is contained in many combination medicines available over the counter. If you take certain products together you may accidentally take too much of this medicine. Read the label of any other medicine you are using to see if it contains dextromethorphan.

What other drugs will affect dextromethorphan?

Before taking dextromethorphan, tell your doctor if you are using any of the following drugs:

• celecoxib (Celebrex);
• cinacalcet (Sensipar);
• darifenacin (Enablex);
• imatinib (Gleevec);
• quinidine (Quinaglute, Quinidex);
• ranolazine (Ranexa)
• ritonavir (Norvir);
• sibutramine (Meridia);
• terbinafine (Lamisil);
• medicines to treat high blood pressure; or
• antidepressant medications such as amitriptyline (Elavil, Etrafon), bupropion (Wellbutrin, Zyban), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with dextromethorphan. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Dextromethorphan side effects

Along with its needed effects, dextromethorphan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Less serious side effects are more likely, such as stomach upset.

General side effects

• Adverse effects have included gastrointestinal disturbances such as stomach upset and diarrhea.

Nervous system

• Frequency not reported: Drowsiness, dizziness, convulsions

Respiratory

• Frequency not reported: Respiratory depression

Gastrointestinal

• Frequency not reported: Vomiting, nausea, diarrhea, abdominal pain, gastrointestinal disturbance

Hypersensitivity

• Rare (less than 0.1%): Fixed-drug eruptions

Psychiatric

• Cases of abuse have been reported.
• Frequency not reported: Mental confusion, excitation, insomnia, abuse

Dermatologic

• Frequency not reported: Rash, angioedema, pruritus, urticaria

Check with your doctor as soon as possible if any of the following side effects occur while taking dextromethorphan:

Symptoms of dextromethorphan overdose:

• blurred vision
• confusion
• difficulty in urination
• drowsiness or dizziness
• nausea or vomiting (severe)
• shakiness and unsteady walk
• slowed breathing
• unusual excitement, nervousness, restlessness, or irritability (severe)

Some side effects of dextromethorphan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare side effects:

• confusion
• constipation
• dizziness (mild)
• drowsiness (mild)
• headache
• nausea or vomiting
• stomach pain

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Stop using dextromethorphan and call your doctor at once if you have any of these serious side effects:

• severe dizziness, anxiety, restless feeling, or nervousness;
• confusion, hallucinations; or
• slow, shallow breathing.

What is Benzocaine?

Benzocaine is a local anesthetic (numbing medication) that acts by preventing transmission of impulses along nerve fibers and at nerve endings that is commonly used as a topical pain reliever. Cepacol Sore Throat Lozenges (Benzocaine) is an ester of paraaminobenzoic acid, with anesthetic activity. Benzocaine binds to the sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited, thereby blocking the initiation and conduction of nerve impulses along nerve fibers and at nerve endings. The action of benzocaine is completely reversible.

What is Methemoglobinemia?

Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin is produced ⁵. Hemoglobin is the protein in red blood cells (RBCs) that carries and distributes oxygen to the body. Methemoglobin is a form of hemoglobin. With methemoglobinemia, the hemoglobin can carry oxygen, but is not able to release it effectively to body tissues.

Danger signs and symptoms of methemoglobinemia include:

• pale, gray, or blue-colored skin, lips and nail beds
• shortness of breath
• fatigue
• confusion
• headache
• light-headedness
• rapid heart rate

Symptoms can occur within minutes to hours after benzocaine use. They can occur after using the drug for the first time, as well as after several uses.

If your child has any of these symptoms after using benzocaine, stop using the product and seek medical help immediately by calling your local emergency services number for an ambulance.

Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.

Complications of methemoglobinemia include ⁶:

• Shock
• Seizures
• Death

Methemoglobinemia Exams and Tests ⁶

A baby with this condition will have a bluish skin color (cyanosis). The health care provider will perform blood tests to diagnose the condition. Tests may include:

• Checking the oxygen level in the blood (pulse oximetry)
• Blood test to check levels of gases in the blood (arterial blood gas analysis)

Methemoglobinemia Treatment ⁶

A medicine called methylene blue is used to treat severe methemoglobinemia. Methylene blue may be unsafe in people who have or may be at risk for a blood disease called glucose-6-phosphate dehydrogenase (G6PD). They should not take this medicine. If you or your child has glucose-6-phosphate dehydrogenase (G6PD), always tell your provider before getting treatment.

Ascorbic acid may also be used to reduce the level of methemoglobin.

Alternative treatments include hyperbaric oxygen therapy, red blood cell transfusion and exchange transfusions.

In most cases of mild acquired methemoglobinemia, no treatment is needed. But you should avoid the medicine or chemical that caused the problem. Severe cases may need a blood transfusion.

Outlook (Prognosis)

People with acquired methemoglobinemia often do very well once the drug, food, or chemical that caused the problem is identified and avoided ⁶.

Important Information Before Using Cepacol Sore Throat Lozenges

Cepacol Sore Throat Lozenges (Benzocaine) used in the mouth or throat may cause methemoglobinemia, a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. Do not use this medicine if you have ever had methemoglobinemia.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

• Do not use this medicine on a child younger than 2 years old without medical advice.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. Use the smallest amount of this medication needed.

Ask a doctor or pharmacist if it is safe for you to use Cepacol Sore Throat Lozenges (Benzocaine) if you have:

• asthma, bronchitis, emphysema, or other breathing disorder;
• heart disease;
• a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or
• if you smoke.

It is not known whether Cepacol Sore Throat Lozenges (Benzocaine) topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether Cepacol Sore Throat Lozenges (Benzocaine) topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Benzocaine Precautions

• Benzocaine topical is considered contraindicated in patients with congenital or idiopathic methemoglobinemia.
• Benzocaine should not be used in infants less than 12 months of age who are receiving treatment with methemoglobin- inducing agents.
• Benzocaine topical is for external use only, and is not intended to be used in or near the eyes.
• Benzocaine crystals may appear as a white precipitate following topical application.
• Do not apply in large quantities or over large, raw, or blistered areas,
• Benzocaine topical is not intended for use on deep or puncture wounds, or serious burns.
• Instruct patients to avoid eating for approximately 1 hour following topical application to oral mucosa.
• Safety and effectiveness of benzocaine sore throat lozenges have not been established in children less than 5 years of age.

Cepacol side effects

Cepacol Sore Throat Lozenges (Benzocaine) used in the mouth or throat may cause a rare but life-threatening condition called methemoglobinemia. In this condition, the amount of oxygen in your blood stream becomes dangerously low. This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Cepacol Sore Throat Lozenges (Benzocaine) in the mouth or throat.

GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• headache, tired feeling, confusion;
• fast heart rate;
• feeling light-headed or short of breath; and
• pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Cepacol Sore Throat Lozenges (Benzocaine) and call your doctor at once if you have:

• severe burning, stinging, or sensitivity where the medicine is applied;
• swelling, warmth, or redness; or
• oozing, blistering, or any signs of infection.

Common side effects may include:

• mild stinging, burning, or itching where the medicine is applied;
• skin tenderness or redness; or
• dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch/default.htm) or by phone (1-800-332-1088).

Along with its needed effects, benzocaine topical (the active ingredient contained in Cepacol Sore Throat Lozenges) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzocaine topical:
Incidence not known

• Headache
• High fever
• Nausea
• Vomiting
• Worsening of pain, redness, swelling, or irritation in or around the mouth

Side effects apply to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

• Dermatologic side effects have included contact dermatitis and urticaria.

Local

• Local side effects have included burning and stinging.

Other

• Other side effects have included edema.

Cardiovascular

• Cardiovascular side effects have included angioedema.

Hematologic

• Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.

1. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm
2. Teething: 4 to 7 Months. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx
3. FDA confirms elevated levels of belladonna in certain homeopathic teething products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm
4. https://www.ada.org/~/media/ADA/Publications/Files/ADA_PatientSmart_Mouth_Sores.pdf?la=en
5. Hartman NR, Mao JJ, Zhou H, Boyne MT, Wasserman AM, Taylor K, Racoosin JA, Patel V, Colatsky T. More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems. Regul Toxicol Pharmacol 2014; 70:182-8.
6. Methemoglobinemia. https://medlineplus.gov/ency/article/000562.htm

What is Gaviscon

Gaviscon is a type of medicine called a ‘reflux suppressant’ that is indicated for the treatment of heartburn (acid reflux) and indigestion. Acid reflux (heartburn) is when stomach acid travels up your food pipe (esophagus) and gives you a burning feeling in your chest. Reflux suppressants like Gaviscon contain alginic acid which is made from seaweed. Alginic acid makes a protective foam layer that floats on top of the contents of your stomach. This stops stomach acid escaping into your food pipe. Gaviscon also contains an antacid that neutralizes excess stomach acid and reduces pain and discomfort.

There are different types of Gaviscon. Ask your doctor or pharmacist which one is best for you.

Gaviscon is used for the relief of:

• heartburn
• acid indigestion
• sour stomach
• upset stomach associated with these symptoms

Gaviscon comes as tablets or liquid in bottles or sachets. It also comes as a powder for babies and children under 2 years old.

You can buy Gaviscon from pharmacies and supermarkets. Some kinds of Gaviscon are available on prescription.

Key facts

• It’s usual to take Gaviscon after meals and at bedtime.
• Do not give Gaviscon to a child under 12 years old, unless their doctor prescribes it.
• It’s safe to take paracetamol at the same time as Gaviscon but don’t have ibuprofen or aspirin with it.
• If you’ve bought Gaviscon without a prescription, do not take it for longer than 7 days without checking with a doctor.
• There are many different types of Gaviscon. Ask your doctor or pharmacist which one is best for you.

When will I feel better after taking Gaviscon?

You should start to feel better soon after taking a dose of Gaviscon. The effect of 1 dose should last for around 4 hours.

If you’ve bought Gaviscon to treat yourself and you don’t feel better after taking it for 7 days, tell your doctor. They may want to do tests or try a different medicine.

Can I drink alcohol with Gaviscon?

Alcohol doesn’t interfere with the way Gaviscon works. But drinking alcohol makes your stomach produce more acid than normal. This can irritate your stomach lining and make your symptoms worse.

Is it safe to take Gaviscon for a long time?

Gaviscon doesn’t usually cause problems when you take it for a long time. Tell your doctor if you need to take it regularly for more than a week.

Are there other indigestion medicines?

There are a number of different medicines for indigestion and heartburn.

• Antacids include Tums (calcium carbonate), Maalox and Milk of Magnesia. These relieve indigestion and heartburn by neutralising the acid in your stomach. They work quickly and make you feel better for a few hours. They’re ideal if you occasionally get stomach acid problems. You can get antacids from pharmacies and supermarkets.
• Proton pump inhibitors (PPIs) reduce the amount of acid your stomach produces. Most PPIs are available on prescription only – they include omeprazole and lansoprazole. You can buy the lowest strength omeprazole and esomeprazole from pharmacies.
• Histamine antagonists (also called H2 blockers) reduce the amount of acid made in your stomach, but they do this in a different way to PPIs. For example, your doctor might prescribe ranitidine (Zantac), cimetidine (Tagamet), famotidine (Pepcid) and nizatidine (Axid). You can also buy famotidine and ranitidine from pharmacies.

Can I take Gaviscon with a proton pump inhibitor?

If your doctor has prescribed a proton pump inhibitor (PPI), such as lansoprazole, to reduce the amount of acid your stomach produces, you can take Gaviscon with it. But take these two medicines separately, leaving a gap of 2 hours between them.

How do I come off Gaviscon?

Usually you can stop taking Gaviscon without reducing the dose first.

If you’ve taken Gaviscon regularly for a long time, talk to your doctor before you stop taking it. Stopping suddenly may mean that the acid stomach contents come up into your food pipe and make your symptoms come back.

Are there other medicines similar to Gaviscon?

Yes, there are similar medicines to Gaviscon. Examples are Acidex (Calcium carbonate + Sodium alginate + Sodium bicarbonate) and Peptac (Calcium carbonate + Sodium alginate + Sodium bicarbonate).

Like Gaviscon, these medicines are reflux suppressants. They work in the same way as Gaviscon, to reduce acid in your stomach and prevent excess acid escaping into your food pipe. They generally work as well as Gaviscon and have similar side effects. However, they may be given in different doses to Gaviscon.

Sometimes, if Gaviscon doesn’t work or agree with you, your doctor or pharmacist may suggest another reflux suppressant. Like Gaviscon, you can buy Peptac or Acidex from pharmacies and supermarkets.

Is the Gaviscon I buy the same as on prescription?

Doctors can only prescribe some kinds of Gaviscon – not the full range available from pharmacies and supermarkets.

Different kinds of Gaviscon contain different ingredients. Speak to your doctor or pharmacist to make sure you get a medicine that suits you.

Can I drive or ride a bike?

Yes, taking Gaviscon shouldn’t affect your ability to drive or ride a bike.

Can lifestyle changes help with heartburn and indigestion?

Making a few changes to your diet and lifestyle may help if you have problems caused by too much stomach acid.

It can help if you:

• keep to a healthy weight or lose weight if you need to – extra weight can put pressure on your stomach and make acid reflux worse
• don’t eat foods that can make your symptoms worse, including rich, spicy and fatty foods, and acidic foods like tomatoes, citrus fruits, salad dressings and fizzy drinks
• cut down on caffeinated drinks, such as tea, coffee and cola, as well as alcohol and smoking
• try not to eat for at least 3 hours before you go to bed
• raise the head of your bed a little
• stop smoking

Who can and can’t take Gaviscon

Gaviscon can be taken by adults, including pregnant and breastfeeding women.

If your baby or child has problems with reflux or indigestion, talk to your doctor as soon as you can. Only treat them with Gaviscon if their doctor prescribes it.

• Never give Gaviscon to children under 12 years old, unless their doctor prescribes it.

To make sure a particular medicine is safe for you, tell your doctor or pharmacist if you have:

• had an allergic reaction to Gaviscon or any other medicines in the past
• been advised to eat a low calcium or low salt diet
• kidney or heart disease
• phenylketonuria (PKU) is a rare but potentially serious inherited disorder. People with Phenylketonuria (PKU) can’t break down the amino acid phenylalanine, which then builds up in the blood and brain. This can lead to brain damage.
• low levels of phosphate in your blood

Gaviscon in Pregnancy and Breastfeeding

Tell your doctor if you’re trying to get pregnant, are already pregnant or if you’re breastfeeding.

Usually Gaviscon is safe to take during pregnancy and while breastfeeding.

If you’re pregnant, it’s best to try to treat indigestion without taking a medicine. For example, it can help to:

• eat smaller meals more often
• avoid fatty or spicy foods
• raise the head of your bed a little

If this doesn’t work, your doctor or midwife may recommend a medicine like Gaviscon.

Gaviscon and Breastfeeding

Gaviscon is safe to take while you’re breastfeeding.

However, if your baby is premature or has health problems, check with your doctor first.

Cautions with other medicines

For safety, tell your doctor or pharmacist if you’re taking any other medicines, including herbal remedies, vitamins or supplements.

Some medicines must not be taken at the same time as Gaviscon. This is because the medicines can interfere with each other.

Don’t take Gaviscon within 2 hours before or after taking:

• antihistamines
• some antibiotics (quinolones and tetracyclines)
• iron tablets
• medicines to treat fungal infections
• beta-blockers (for heart problems)
• penicillamine (for rheumatoid arthritis)
• steroids (for inflammatory and autoimmune disorders)
• antipsychotic medicines (for mental health problems like bipolar disease and schizophrenia)
• chloroquine (for malaria)
• estramustine (for prostate cancer)
• bisphosphonates such as alendronic acid (to treat and prevent bone problems such as osteoporosis)
• levothyroxine
• a protein pump inhibitor (PPI) such as omeprazole and lansoprazole

It’s safe to take paracetamol at the same time as Gaviscon. Do not take other painkillers, like ibuprofen or aspirin, with Gaviscon without talking to your doctor or pharmacist first. These can make your symptoms worse.

Mixing Gaviscon with herbal remedies and supplements

There are no known problems with taking herbal remedies and supplements alongside Gaviscon.

Gaviscon vs Maalox

Maalox is a drug indicated for the treatment of heartburn (acid reflux) and indigestion. Maalox active ingredients (in each 5 mL teaspoon) are Aluminum hydroxide (equivalent to dried gel, USP) 200 mg + Magnesium hydroxide 200 mg + Simethicone 20 mg

Simethicone is used to treat the symptoms of gas such as uncomfortable or painful pressure, fullness, and bloating.

Simethicone allows gas bubbles in the stomach and intestines to come together more easily, which allows for easier passage of gas.

Simethicone is used to relieve painful pressure caused by excess gas in the stomach and intestines. Simethicone is for use in babies, children, and adults.

Maalox is used for the relief of:

• acid indigestion
• heartburn
• sour stomach
• upset stomach associated with these symptoms
• pressure and bloating commonly referred to as gas

Inactive ingredients: butylparaben, carboxymethylcellulose sodium, flavor, hypromellose, microcrystalline cellulose, propylparaben, purified water, saccharin sodium, simethicone emulsion, sorbitol

Other information

• each teaspoon contains: calcium 25 mg and magnesium 85 mg
• store at 20°-25°C (68°-77°F)
• does not meet USP requirements for preservative effectiveness

Maalox Directions of Use

• shake well before using
• Adults and children 12 years and older: take 2-4 tsp (10-20 mL) up to 4 times a day or as directed by a doctor
• Children under 12: ask a doctor

Maalox Warnings

Ask a doctor before use if you have:

• kidney disease
• a magnesium-restricted diet

Ask a doctor or pharmacist before use if you are:

• now taking a prescription drug. Antacids may interact with certain prescription drugs.

When using Maalox

• do not exceed 16 teaspoonsful (80 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks unless directed by a doctor

Keep out of reach of children.

How and when to take Gaviscon

It’s usual to take Gaviscon up to 4 times a day. It’s best to take it after meals and at bedtime. This is usually when the pain and discomfort is worst. If your doctor has prescribed Gaviscon, take it when they tell you to.

You can get Gaviscon as tablets. You can also get it as a liquid in bottles or sachets.

It comes as a powder for babies and children under 2 years old. You mix the powder with cool boiled water or formula milk.

How much should I take?

The dose depends on the type of Gaviscon you’re taking. Follow the instructions on the packaging or, if your doctor has prescribed it, take the dose they tell you to.

How often should I have Gaviscon?

• If you get occasional mild heartburn or indigestion, only take Gaviscon when you need it.
• If you often have heartburn or indigestion, take Gaviscon regularly after meals and at bedtime – up to 4 times a day – whether or not you have symptoms.
• If you’ve been taking Gaviscon for more than 7 days and you’re still feeling uncomfortable or in pain, talk to your doctor.

How long will I take Gaviscon for?

Depending on the reason you’re taking Gaviscon, you may only need it when you have symptoms. Or you may need to take it for a few weeks or months – or for many years.

Talk to your doctor about what is best for you.

What if I forget to take Gaviscon?

If you usually take Gaviscon regularly but forget to take a dose, don’t double your dose the next time. Just leave out the missed dose and take your next dose as normal.

If you forget doses often, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to help you remember to take your medicine.

What if I take too much?

Taking too much Gaviscon by accident may cause side effects such as wind and bloating (when your tummy feels tight and full of gas). This is unlikely to cause you any harm. If you are worried, talk to your doctor or pharmacist.

Gaviscon dosage

Gaviscon Liquids

Gaviscon Regular Strength Liquid active ingredients (in each 15 mL tablespoonful) are Aluminum hydroxide 95 mg + Magnesium carbonate 358mg

• Inactive ingredients (Regular Strength): benzyl alcohol, D&C yellow #10, edetate disodium, FD&C blue #1, flavor, glycerin, saccharin sodium, sodium alginate, sorbitol solution, water, xanthan gum
• Each tablespoon (15mL) contains: magnesium 115mg, sodium 52mg
• Store at up to 25°C (77°F); avoid freezing
• Keep tightly closed

Gaviscon Extra Strength Liquid active ingredients (in each 5 mL teaspoonful) are Aluminum hydroxide 254 mg + Magnesium carbonate 237.5mg

• Inactive ingredients (Extra Strength): benzyl alcohol, edetate disodium, flavor, glycerin, saccharin sodium, simethicone emulsion, sodium alginate, sorbitol solution, water, xanthan gum
• Each teaspoon (5mL) contains: magnesium 80mg, sodium 14mg
• Store at up to 25°C (77°F); avoid freezing
• Keep tightly closed

Gaviscon Liquids Directions of Use

• Shake well.
• Take after meals or at bedtime.
• Dispense product only by spoon or other measuring device provided.
• Take 1-2 tablespoons (15ml to 30ml) 4x a day for Regular Strength 
• OR
• 2-4 teaspoonfuls (10ml to 20ml) 4x a day for Extra Strength, or as directed by a doctor.

Gaviscon Liquid Warnings

• Do not use if you have kidney disease

Ask a doctor or pharmacist before use if you are:

• taking a prescription drug. Antacids may interact with certain prescription drugs.
• if you are on a sodium-restricted diet

When using this product (Regular Strength)

• do not take more than 8 tablespoonfuls in 24 hours
• do not use the maximum dosage for more than 2 weeks
• laxative effect may occur

When using this product (Extra Strength)

• do not take more than 16 teaspoonfuls in 24 hours
• do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor
• laxative effect may occur

Keep out of reach of children.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Gaviscon Chewable Tablets

Gaviscon Regular Strength Chewable Tablet active ingredients (in each tablet) are dried Aluminum hydroxide gel 80mg + Magnesium trisilicate 14.2mg

• Inactive ingredients (Regular Strength): acesulfame k, alginic acid, artificial flavor, calcium stearate, corn starch, corn syrup solids, mannitol, sodium bicarbonate, stearic acid, sucrose
• Each tablet contains: magnesium 5mg, sodium 21 mg
• Store at up to 25°C (77°F) in a dry place

Gaviscon Extra Strength Chewable Tablet active ingredients (in each tablet) are Aluminum hydroxide 160 mg + Magnesium carbonate 105mg

• Inactive ingredients (Extra Strength): alginic acid, calcium stearate, flavor, sodium bicarbonate, and sucrose. May contain stearic acid. Contains sorbitol or mannitol. May contain starch.
• Each tablet contains: magnesium 35mg, sodium 20mg
• Store at up to 25°C (77°F) in a dry place

Gaviscon Chewable Tablets Directions of Use

• DO NOT SWALLOW WHOLE.
• Chew 2-4 tablets after meals and at bedtime as needed (up to 4x a day), or as directed by a doctor. For best results follow by a half glass of water or other liquid.
• Do not take more than 16 Regular Strength tablets in 24 hours.

Gaviscon Regular Strength Chewable Tablets Warnings

Do NOT use

• for peptic ulcers
• if you have trouble swallowing

Ask a doctor before use if you have:

• kidney disease
• a sodium restricted diet

Ask a doctor or pharmacist if you:

• are taking a prescription drug. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if:

• heartburn or stomach pain continues
• you need to take this product for more than 14 days

Keep out of reach of children.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Gaviscon Extra Strength Chewable Tablets Warnings

Ask a doctor or pharmacist before use if you are:

• taking a prescription drug. Antacids may interact with certain prescription drugs.
• if you are on a sodium-restricted diet

When using this product:

• do not take more than 16 tablets in 24 hours
• do not use the maximum dosage for more than 2 weeks

Keep out of reach of children.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Gaviscon side effects

Gaviscon is a very safe medicine. Most people who take it don’t have any side effects. If you do get a side effect, it’s likely to be mild and will go away when you stop taking Gaviscon.

Some types of Gaviscon may be more likely to make you feel sick or cause vomiting, constipation or diarrhea because of their ingredients. Talk to your doctor or pharmacist if you notice any side effects that bother you or don’t go away.

Serious allergic reaction

In very rare cases, it’s possible to have an allergic reaction to Gaviscon. This happens in less than 1 in 10,000 patients. If you have an allergic reaction stop taking Gaviscon and contact a doctor straight away.

• A serious allergic reaction is an emergency. Contact a doctor straight away if you think you or someone around you is having a serious allergic reaction.

The warning signs of a serious allergic reaction are:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• wheezing
• tightness in the chest or throat
• having trouble breathing or talking
• swelling of the mouth, face, lips, tongue or throat

These are not all the side effects of Gaviscon. For a full list see the leaflet inside your medicines packet.

What is Dimetapp

Dimetapp contains the active ingredients Brompheniramine [Antihistamine] and Pseudoephedrine [Nasal decongestant].

Dimetapp Elixir, Liquid, and Syrup medicine is used:

• to treat nose stuffiness.
• to ease allergy signs.

Other Dimetapp brands contain different active ingredients depending on their uses.

What is brompheniramine?

Brompheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Brompheniramine is used to treat runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.

Brompheniramine Important Information

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Before taking Brompheniramine

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, heart disease, or a thyroid disorder.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine if you have:

• a blockage in your digestive tract (stomach or intestines), a colostomy or ileostomy;
• liver or kidney disease;
• cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;
• enlarged prostate or urination problems; or
• if you take potassium.

FDA pregnancy category C: It is not known whether brompheniramine will harm an unborn baby. Do not use this medicine without medical advice if you are pregnant.

Brompheniramine may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

What should I avoid while taking brompheniramine?

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Drinking alcohol can increase certain side effects of brompheniramine.

Ask a doctor or pharmacist before using any other cold, cough, allergy, or sleep medicine. Antihistamines are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Brompheniramine can decrease sweating and you may be more prone to heat stroke.

Brompheniramine side effects

Side effects of brompheniramine

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling nervous and excitable.
• Dry mouth.
• Dry nose.

Get emergency medical help if you have any of these signs of an allergic reaction:

• hives;
• difficult breathing;
• swelling of your face, lips, tongue, or throat.

Stop using brompheniramine and call your doctor at once if you have a serious side effect such as:

• fast or uneven heart rate;
• mood changes;
• tremor, seizure (convulsions);
• easy bruising or bleeding, unusual weakness;
• feeling short of breath; or
• urinating less than usual or not at all.

Less serious side effects may include:

• dizziness, drowsiness;
• dry mouth, nose, or throat;
• constipation;
• blurred vision; or
• feeling nervous or restless.

Nervous system

Nervous system side effects have included central nervous system (CNS) depression, resulting in drowsiness and sedation in nearly 50% of patients treated. This effect has often been transient and ceased with continued use. Motor skills have be impaired and patients should be advised to avoid tasks which require attention. Patients should also avoid concomitant use with alcohol and other sedative-hypnotic drugs. Dyskinesias have rarely been reported following chronic use of brompheniramine.

A few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of brompheniramine extended over a period of up to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms in these patients. Spasmodic torticollis has been reported in a child given brompheniramine over an eight month period.

Gastrointestinal

Gastrointestinal side effects have include nausea, dry mouth and constipation.

Cardiovascular

Cardiovascular effects of brompheniramine have included hypotension, tachycardia, and palpitations.

Ocular

Ocular side effects have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.

Genitourinary

Genitourinary side effects have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention.

Hematologic

Hematologic side effects have included rare cases of hemolytic anemia, thrombocytopenia, and agranulocytosis.

What are some side effects that I need to call my doctor about right away?

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug.

Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath.
• Change in balance.
• Change in eyesight.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Very bad sore throat.
• Fever or chills.
• Trouble passing urine.
• Any unexplained bruising or bleeding.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Feeling confused.
• Restlessness.
• Shakiness.
• Seizures.

What is pseudoephedrine?

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian tubes.

Pseudoephedrine Important information

Do not give pseudoephedrine to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant. Do not use pseudoephedrine if you have used a MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking pseudoephedrine

Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Do not use this medication if you are allergic to pseudoephedrine or to other decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine if you have:

• heart disease or high blood pressure;
• diabetes; or
• a thyroid disorder.
• Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

FDA pregnancy category C: It is not known whether pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use pseudoephedrine without telling your doctor if you are breast-feeding a baby.

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

Pseudoephedrine Pregnancy and Breastfeeding Warnings

Pseudoephedrine Pregnancy Warnings

Doses of 35 to 50 times the human daily dose to rabbits and rats, respectively, have not produced teratogenic effects. A case-controlled surveillance study reported an elevated relative risk (3.2) of gastroschisis with first-trimester use in 76 cases. The authors hypothesized vascular disruption as the etiology of gastroschisis. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to this drug were recorded and 1919 exposures anytime during pregnancy. A total of 37 birth defects were reported with first trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980 through 1983 Medicaid data. Seven of the nine cases occurred in 3752 woman who had taken pseudoephedrine for a relative risk of 1.8. There are no adequate and well controlled studies in pregnant women.

Pseudoephedrine Breastfeeding Warnings

Based on limited data, it has been estimated that 0.5% to 0.7% of the mother’s dose is excreted into breast milk over 24 hours. In 1 study, irritability was reported in up to 20% of infants. A 24% mean decrease in milk production was observed after a single 60 mg dose in 8 nursing mothers.

Caution is recommended

Excreted into human milk: Yes

Comments:

• Single doses are unlikely to harm a nursing infant, but may cause irritability or disturbed sleep.
• Repeated doses may interfere with lactation in mothers who are having difficulties producing sufficient milk or in those whose lactation is not well established.

What should I avoid whilst taking pseudoephedrine?

Avoid taking pseudoephedrine if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.

Pseudoephedrine side effects

Some side effects of pseudoephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them.

The most commonly reported adverse effects have included cardiovascular and (e.g. elevated blood pressure, tachycardia, or arrhythmias), CNS stimulation (e.g. restlessness, insomnia, anxiety, tremors, and rarely hallucinations), skin rashes, and urinary retention.

More common side effects:

• nervousness
• restlessness
• trouble in sleeping

Less common side effects:

• difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness

Cardiovascular

• Frequency not reported: Tachycardia, palpitations, arrhythmia, hypertension, impaired circulation to the extremities

Nervous system

• Frequency not reported: Headache, tremor

Gastrointestinal

• Frequency not reported: Dry mouth, nausea, vomiting

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions including cross-sensitivity with other sympathomimetic

Psychiatric

• Rare (less than 0.1%): Hallucinations
• Frequency not reported: Restlessness, insomnia, sleep disturbances, anxiety, excitability

Genitourinary

• Frequency not reported: Urinary retention, especially in men with prostatic enlargement

Ocular

• Frequency not reported: Angle-closure glaucoma

Dermatologic

• Frequency not reported: Skin rashes, fixed drug eruption in the form of erythematous nodular patches

Other side effects

• Post marketing reports: False-positive amphetamine immunoassay
• False-positives can occur far below the published threshold indicating that cross-reactivity in human specimens is sometimes greater than the limits reported.

Get emergency medical help if you have any of these signs of an allergic reaction to pseudoephedrine:

• hives;
• difficulty breathing;
• swelling of your face, lips, tongue, or throat.

Stop using pseudoephedrine and call your doctor at once if you have a serious side effect such as:

• fast, pounding, or uneven heartbeat;
• severe dizziness or anxiety;
• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
• dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).

Less serious pseudoephedrine side effects may include:

• loss of appetite;
• warmth, tingling, or redness under your skin;
• feeling restless or excited (especially in children);
• sleep problems (insomnia); or
• skin rash or itching.

Check with your doctor as soon as possible if any of the following side effects occur while taking pseudoephedrine:

Rare side effects – more common with high doses:

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

Symptoms of pseudoephedrine overdose:

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

What do I need to tell my doctor before I take Dimetapp?

• If you have an allergy to brompheniramine, pseudoephedrine, or any other part of Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) within 14 days of those drugs can cause very bad high blood pressure.

This is not a list of all drugs or health problems that interact with Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Dimetapp?

• Tell all of your health care providers that you take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup). This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) affects you.
• Avoid drinking alcohol while taking Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Dimetapp best taken?

Use Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Measure liquid doses carefully. Use the measuring device that comes with Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup). If there is none, ask the pharmacist for a device to measure Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup).

What do I do if I miss a dose?

• If you take Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Dimetapp (brompheniramine and pseudoephedrine elixir, liquid, and syrup) is taken on an as needed basis. Do not take more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Dimetapp?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

If Dimetapp OVERDOSE is suspected

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

Be ready to tell or show what was taken, how much, and when it happened.

Dimetapp Formula Finder

Children’s Dimetapp Cold and Allergy

• Active ingredients (in each 10 ml): Brompheniramine maleate USP 2 mg [Antihistamine] + Phenylephrine HCl USP 5 mg [Nasal decongestant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each 10 ml contains: sodium 6 mg
• store at 20-25°C (68-77°F)

Children’s Dimetapp Cold and Allergy Uses:

• Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Children’s Dimetapp Cold and Allergy Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema, asthma, or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Cold and Allergy Directions of Use

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

Table 1. Children’s Dimetapp Cold and Allergy Dosage Chart

Children’s Dimetapp Cold and Cough

• Active ingredients (in each 10 ml): Brompheniramine maleate USP 2 mg [Antihistamine] + Phenylephrine HCl USP 5 mg [Nasal decongestant] + Dextromethorphan HBr, USP 10 mg [Cough suppressant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each 10 ml contains: sodium 6 mg
• store at 20-25°C (68-77°F)

Children’s Dimetapp Cold and Cough Uses:

• Temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Children’s Dimetapp Cold and Cough Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are:

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Cold and Cough Directions of Use

• do not take more than 6 doses in any 24-hour period
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

Table 2. Children’s Dimetapp Cold and Cough Dosage Chart

Children’s Dimetapp Long Acting Cough Plus Cold

• Active ingredients (in each 5 ml teaspoon): Chlorpheniramine maleate, USP 1.0 mg [Antihistamine] + Dextromethorphan HBr, USP 7.5 mg [Cough suppressant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each teaspoon contains: sodium 3 mg
• store at 20-25°C (68-77°F)
• dosage cup provided

Children’s Dimetapp Long Acting Cough Plus Cold Uses:

• Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Children’s Dimetapp Long Acting Cough Plus Cold Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• trouble urinating due to an enlarged prostate gland
• glaucoma
• a cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Long Acting Cough Plus Cold Directions of Use

• do not take more than 4 doses in any 24-hour period
• ml = milliliter

Table 3. Children’s Dimetapp Long Acting Cough Plus Cold Dosage Chart

Children’s Dimetapp Multi-Symptom Cold and Flu

• Active ingredients (in each 10 ml): Acetaminophen, USP 320 mg [Pain reliever & Fever reducer] + Diphenhydramine HCl, USP 12.5 mg [Antihistamine & Cough suppressant] + Phenylephrine HCl, USP 5 mg [Nasal decongestant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, edetate disodium, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each 10 ml contains: sodium 7 mg
• store at 20-25°C (68-77°F)

Children’s Dimetapp Multi-Symptom Cold and Flu Uses:

• Temporarily relieves these symptoms associated with a cold, or flu:
  • headache
  • sore throat
  • fever
  • minor aches and pains
• Temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Children’s Dimetapp Multi-Symptom Cold and Flu Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if user takes

• more than 5 doses in any 24-hour period, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do NOT use

• to sedate a child or to make a child sleepy
• in a child under 6 years of age
• if user is now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if user has:

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if user is:

• taking the blood thinning drug warfarin
• taking any other oral nasal decongestant or stimulant
• taking any other pain reliever/fever reducer
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• user gets nervous, dizzy, or sleepless
• pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.

Children’s Dimetapp Multi-Symptom Cold and Flu Directions of Use

• do not take more than 5 doses in any 24-hour period
• do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
• measure only with dosage cup provided
• keep dosage cup with product
• ml = milliliter

Table 4. Children’s Dimetapp Multi-Symptom Cold and Flu Dosage Chart

Children’s Dimetapp Nighttime Cold and Congestion

• Active ingredients (in each 5 ml teaspoon): Diphenhydramine HCl, USP 6.25 mg [Antihistamine & Cough suppressant] + Phenylephrine HCl, USP 2.5 mg [Nasal decongestant]
• Inactive ingredients: anhydrous citric acid, artificial flavor, FD&C blue no.1, FD&C red no. 40, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Other information

• each teaspoon contains: sodium 4 mg
• dosage cup provided
• store at 20-25°C (68-77°F)

Children’s Dimetapp Nighttime Cold and Congestion Uses:

• Temporarily relieves these symptoms occurring with a cold, hay fever, or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • nasal congestion
  • cough

Children’s Dimetapp Nighttime Cold and Congestion Warnings

Do NOT use

• to sedate a child or to make a child sleepy
• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are:

• taking any other oral nasal decongestant or stimulant
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Children’s Dimetapp Nighttime Cold and Congestion Directions of Use

• do not take more than 6 doses in any 24-hour period
• do not exceed recommended dosage
• ml = milliliter

Table 5. Children’s Dimetapp Nighttime Cold and Congestion Dosage Chart

Dimetapp Elixir

• Active ingredients (in each 5 ml teaspoon): Brompheniramine maleate, USP 1 mg [Antihistamine] + Pseudoephedrine HCl, USP 15 mg [Nasal decongestant]
• Inactive ingredients: artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

Other information

• store at 20-25°C (68-77°F)
• not a United States Pharmacopeia (USP) elixir
• dosage cup provided
• Pleasant tasting – children find its great grape taste easy to take.
• Adults like it, too – especially those who have difficulty swallowing tablets or capsules.

Dimetapp Elixir Uses:

• Temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Dimetapp Elixir Warnings

Do NOT use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dimetapp Elixir Directions of Use

• do not take more than 4 doses in any 24-hour period
• ml = milliliter

Table 6. Dimetapp Elixir Dosage Chart

Dimetapp Pediatric Elixir

• Active ingredients (in each 5 ml teaspoon): Brompheniramine maleate, USP 1 mg [Antihistamine] + Pseudoephedrine HCl, USP 15 mg [Nasal decongestant]
• Inactive ingredients: artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, high fructose corn syrup, propylene glycol, saccharin sodium, sodium benzoate, sorbitol, purified water

Other information

• store at 20-25°C (68-77°F)
• not a United States Pharmacopeia (USP) elixir
• dosage cup provided

Dimetapp Pediatric Elixir Uses:

• Temporarily relieves nasal and sinus congestion due to the common cold, hay fever or other upper respiratory allergies, or associated with sinusitis
• Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
• Temporarily restores freer breathing through the nose

Dimetapp Pediatric Elixir Warnings

Do NOT use

• If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• excitability may occur, especially in children

Stop use and ask a doctor if:

• you get nervous, dizzy, or sleepless
• symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Dimetapp Pediatric Elixir Directions of Use

• do not exceed recommended dosage
• ml = milliliter

Table 7. Dimetapp Pediatric Elixir Dosage Chart

What is Excedrin-Migraine

Excedrin-Migraine is a medicine that contains active ingredients in a combination of Acetaminophen (paracetamol), Aspirin, and Caffeine. Acetaminophen is a pain reliever and a fever reducer. Aspirin is acetylsalicylic acid in a group of drugs called salicylates, classified as a non-steroidal anti-inflammatory drug (NSAID). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation. Caffeine is a central nervous system stimulant. Caffeine relaxes muscle contractions in blood vessels to improve blood flow.

Excedrin-Migraine is used to treat migraine headaches.

Interestingly, the products sold as Excedrin, Excedrin Menstrual and Excedrin Tension Headache contain identical active ingredients even though advertised for different conditions!

• If Excedrin-Migraine isn’t effectively controlling your migraines, your doctor may refer you to a specialist migraine clinic for further investigation and treatment. A specialist may recommend other treatments such as transcranial magnetic stimulation.
• Transcranial magnetic stimulation involves holding a small electrical device to your head that delivers magnetic pulses through your skin. It’s not clear exactly how transcranial magnetic stimulation works in treating migraines, but studies have shown that using it at the start of a migraine can reduce its severity. It can also be used in combination with the medications mentioned above without interfering with them. However, transcranial magnetic stimulation isn’t a cure for migraines and it doesn’t work for everyone. The evidence for its effectiveness isn’t strong and is limited to people who have migraine with aura. There’s also little evidence about the potential long-term effects of the treatment, although studies into the treatment have so far only reported minor and temporary side effects, including:
  • slight dizziness
  • drowsiness and tiredness
  • a muscle tremor that can make it difficult to stand
  • irritability

Excedrin-Migraine ingredients

The active ingredients in Excedrin-Migraine are Acetaminophen 250 mg + Aspirin 250 mg + Caffeine 65 mg.

Acetaminophen

Acetaminophen (paracetamol) is a common painkiller used to treat aches and pain. It can also be used to reduce fever (100.4 °F [38 °C] and above).

Acetaminophen (paracetamol) is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Acetaminophen (paracetamol) is also available combined with other painkillers and anti-sickness medicines. It’s an ingredient in a wide range of cold and flu remedies.

Key facts on Acetaminophen

• Acetaminophen (paracetamol) takes up to an hour to work.
• The usual dose of Acetaminophen (paracetamol) is one or two 500mg tablets at a time.
• Don’t take Acetaminophen (paracetamol) with other medicines containing Acetaminophen (paracetamol).

Who can and can’t take Acetaminophen

Most people can take Acetaminophen (paracetamol) safely, including pregnant and breastfeeding women.

However, some people need to take extra care with Acetaminophen (paracetamol).

Check with your doctor or pharmacist if you:

• have had an allergic reaction to Acetaminophen (paracetamol) or any other medicines in the past
• have liver or kidney problems
• regularly drink more than the maximum recommended amount of alcohol (14 units a week)
• take medicine for epilepsy
• take medicine for tuberculosis (TB)
• take the blood-thinner warfarin and you may need to take Acetaminophen (paracetamol) on a regular basis

Before taking acetaminophen

• tell your doctor and pharmacist if you are allergic to acetaminophen, any other medications, or any of the ingredients in the product. Ask your pharmacist or check the label on the package for a list of ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention anticoagulants (‘blood thinners’) such as warfarin (Coumadin); isoniazid (INH); certain medications for seizures including carbamazepine (Tegretol), phenobarbital, and phenytoin (Dilantin); medications for pain, fever, coughs, and colds; and phenothiazines (medications for mental illness and nausea). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever developed a rash after taking acetaminophen.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen, call your doctor.
• if you drink three or more alcoholic beverages every day, do not take acetaminophen. Ask your doctor or pharmacist about the safe use of alcoholic beverages while taking acetaminophen.
• you should know that combination acetaminophen products for cough and colds that contain nasal decongestants, antihistamines, cough suppressants, and expectorants should not be used in children younger than 2 years of age. Use of these medications in young children can cause serious and life-threatening effects or death. In children 2 through 11 years of age, combination cough and cold products should be used carefully and only according to the directions on the label.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that some brands of acetaminophen chewable tablets may be sweetened with aspartame, a source of phenylalanine.

Side effects of Acetaminophen

Acetaminophen (paracetamol) very rarely causes side effects if you take it at the right dosage.

If you’re worried about a side effect or notice anything unusual, talk to your pharmacist or doctor.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Acetaminophen (paracetamol).

If you experience any of the following symptoms, stop taking acetaminophen and call your doctor immediately or get emergency medical attention:

• red, peeling or blistering skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

Acetaminophen may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

Cautions with other medicines

It’s safe to take Acetaminophen (paracetamol) with most prescription medicines, including antibiotics.

Acetaminophen (paracetamol) isn’t suitable for some people. Talk to your doctor if you take:

• the blood-thinner warfarin (Acetaminophen (paracetamol) can increase the risk of bleeding if you take it regularly)
• medicine to treat epilepsy
• medicine to treat tuberculosis (TB)

Mixing Acetaminophen (paracetamol) with herbal remedies and supplements

Check with your doctor or pharmacist if you’re taking the herbal medicine St John’s wort for depression as you may need to reduce your Acetaminophen (paracetamol) dose.

Otherwise, Acetaminophen (paracetamol) isn’t generally affected by also taking herbal remedies or supplements.

Acetaminophen Overdose

An overdose of acetaminophen can damage your liver or cause death. If someone takes more than the recommended dose of acetaminophen, get medical help immediately, even if the person does not have any symptoms.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Symptoms of acetaminophen overdose may include the following:

• nausea
• vomiting
• loss of appetite
• sweating
• extreme tiredness
• unusual bleeding or bruising
• pain in the upper right part of the stomach
• yellowing of the skin or eyes (jaundice)
• flu-like symptoms

Aspirin

Aspirin is also known as acetylsalicylic acid in a class of drug called nonsteroidal anti-inflammatory drugs (NSAIDs) that is similar to non-steroidal inflammatory (NSAIDs) like Ibuprofen (Motrin or Advil) and naproxen (Aleve). Aspirin works by reducing substances in your body that cause pain, fever, and inflammation.

Aspirin can prevent the formation of blood clots which can make it useful in treating or preventing some conditions like heart attacks and strokes. The dosage for aspirin can range from 50 to 6000 milligrams (mg) per day depending on the condition being treated, and aspirin may be used in combination with other medications.

Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina).

Aspirin is a common medicine that has a number of uses, from relieving pain to reducing the risk of serious problems such as heart attacks and strokes.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin-Migraine.

Aspirin can be used to treat:

• Mild to moderate pain
• Fever
• Swollen, red and tender body tissues
• Rheumatoid arthritis
• Rheumatic fever ¹

It is also used in the prevention of blood clots, heart attacks, strokes and bowel cancer ¹.

Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Uses for aspirin

At high doses – usually 300mg – aspirin can relieve pain, reduce a high temperature (fever) and reduce swelling.

Aspirin is often used for short-term relief from:

• headaches and migraines
• toothache
• period pains
• general aches and pains
• colds and flu

Long-term treatment with low doses of aspirin – usually 75mg – has an antiplatelet effect, which means it makes the blood less sticky and can stop blood clots developing.

A doctor may recommend low doses of aspirin (75mg) if you have or have had:

• a heart attack or angina
• a stroke or transient ischemic attack (TIA)
• peripheral arterial disease
• coronary artery bypass surgery or another operation on your heart or blood vessels

Aspirin may also be prescribed for children after heart surgery or to treat Kawasaki disease. But it shouldn’t be given to anyone under 16 years old without medical supervision.

Who can and can’t take Aspirin

Most people can take aspirin safely. But you should get advice from a pharmacist or doctor before taking it if you:

• have had an allergic reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, in the past
• have asthma
• have had stomach ulcers in the past
• have severe liver or kidney problems
• have hemophilia or another bleeding disorder
• have uncontrolled high blood pressure
• are looking for medication for a child under 16 – medication containing aspirin shouldn’t be given to children under 16
• are over 65 years of age
• are pregnant, breastfeeding or trying to get pregnant
• are taking other medications

You may still be able to take aspirin in these cases, but you should only do so if advised that it’s safe by a healthcare professional.

If you can’t take aspirin, a different medicine, such as paracetamol (for pain) or clopidogrel (to prevent blood clots), may be recommended instead.

Before taking aspirin

• tell your doctor and pharmacist if you are allergic to aspirin, other medications for pain or fever, tartrazine dye, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetazolamide (Diamox); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants (‘blood thinners’) such as warfarin (Coumadin) and heparin; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); diuretics (‘water pills’); medications for diabetes or arthritis; medications for gout such as probenecid and sulfinpyrazone (Anturane); methotrexate (Trexall); other nonsteroidal anti-inflammatory drugs (NSAIDs) such as naproxen (Aleve, Naprosyn); phenytoin (Dilantin); and valproic acid (Depakene, Depakote). Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.
• if you are taking aspirin on a regular basis to prevent heart attack or stroke, do not take ibuprofen (Advil, Motrin) to treat pain or fever without talking to your doctor. Your doctor will probably tell you to allow some time to pass between taking your daily dose of aspirin and taking a dose of ibuprofen.
  tell your doctor if you have or have ever had asthma, frequent stuffed or runny nose, or nasal polyps (growths on the linings of the nose). If you have these conditions, there is a risk that you will have an allergic reaction to aspirin. Your doctor may tell you that you should not take aspirin.
• tell your doctor if you often have heartburn, upset stomach, or stomach pain and if you have or have ever had ulcers, anemia, bleeding problems such as hemophilia, or kidney or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking aspirin, call your doctor. Aspirin may harm the fetus and cause problems with delivery if it is taken during the last few months of pregnancy.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking aspirin.
• if you drink three or more alcoholic drinks every day, ask your doctor if you should take aspirin or other medications for pain and fever.

How to take aspirin

Your pharmacist or doctor can tell you how often to take your aspirin and how much you should take. You can also check the recommendations in the leaflet that comes with your medicine.

Generally speaking:

• high-dose aspirin (to relieve pain) can be taken three or four times a day, with at least four hours between each dose, until your symptoms improve
• low-dose aspirin (to prevent blood clots) is taken once a day, usually for the rest of your life

Some medicine leaflets advise taking aspirin with water, while others may recommend taking it before or after food.

Follow the instructions in the leaflet or label that comes with your medicine. Ask your pharmacist if you’re not sure.

Aspirin interactions with other medicines, food and alcohol

Aspirin can potentially interact with other medications, including some complementary and herbal medicines, which could alter their effects or increase your risk of side effects.

Medicines that can interact with aspirin include:

• NSAIDs – such as ibuprofen or naproxen
• steroid medication – such as prednisolone
• anticoagulant medicines – such as warfarin or heparin
• SSRI antidepressants – such as citalopram, fluoxetine or paroxetine
• some medications used to treat high blood pressure – such as ACE inhibitors or diuretics
• some medicines used to treat epilepsy – such as phenytoin
• other medicines containing aspirin – including cold and flu remedies where aspirin is one of the ingredients

Taking aspirin with warfarin (anticoagulant medicine or blood thinner) or some blood pressure medicines may increase the risk of bleeding.

This is not a complete list. If you want to check whether a medicine is safe to take with aspirin, ask your doctor or pharmacist, or read the leaflet that comes with the medicine.

There are no known interactions between aspirin and food.

The risk of bleeding in the stomach may be higher if you drink alcohol while taking aspirin, so you may want to consider reducing how much you drink or avoiding alcohol completely.

Side effects of aspirin

Like all medications, there’s a risk of side effects from aspirin.

The most common side effects are:

• Indigestion and stomach aches – taking your medicine with food may help reduce this risk
• Bleeding or bruising more easily than normal

Other side effects of aspirin:

• Dizziness, ringing in the ears, blurred vision
• Drowsiness, fatigue, depression
• Thirst, sweating, fluid retention, swollen ankles
• Abdominal discomfort or bloating
• Nausea, heartburn, diarrhea, constipation

Uncommon and rare side effects include:

• hives – a raised, itchy rash
• tinnitus – hearing sounds that come from inside your body
• breathing difficulties or an asthma attack
• an allergic reaction – this can cause breathing problems, swelling of the mouth, lips or throat, and a sudden rash
• bleeding in the stomach – this can cause dark, tar-like stools or vomiting blood
• bleeding in the brain – this can cause a sudden, severe headache, vision problems and stroke symptoms, such as slurred speech and weakness on one side of the body

Long-term effects of taking aspirin:

Regular use of aspirin may eventually cause the following effects. It’s best to discuss the side effects of long term use with a medical practitioner.

• Anemia (low red blood cell count)
• Easy bruising and abnormal bleeding
• Inflamed stomach lining, stomach bleeding and peptic ulcers
• Vomiting blood that may look like coffee grounds and bowel motions that look like black tar
• An allergic-type reaction, wheezy breathing and a tightness in the chest in adults, hives in children, and in some rare cases swelling of the face, lips, tongue or around the eyes
• Reduced kidney and liver function

Speak to your doctor if you experience any concerning or troublesome side effects while taking aspirin.

Call your emergency number for an ambulance or go to your nearest accident and emergency (A&E) department if you think you’re having a severe allergic reaction, or you have symptoms of bleeding in your stomach or brain.

Aspirin Overdose

If the dose is too high, you might overdose. If you have any of these symptoms, call an ambulance straight away by dialing your local emergency number.

• Headaches
• Confusion
• Fever
• Deafness
• Vomiting
• Rapid and shallow breathing
• Seizures
• Stop breathing, coma and death
• Burning pain in the throat or stomach
• Decreased urination
• Restlessness
• Irritability
• Talking a lot and saying things that do not make sense
• Fear or nervousness
• Dizziness
• Double vision
• Uncontrollable shaking of a part of the body
• Abnormally excited mood
• Hallucination (seeing things or hearing voices that are not there)
• Drowsiness
• Loss of consciousness for a period of time

Caffeine

Caffeine is a stimulant drug, which means it speeds up the messages traveling between the brain and your body.

It’s found in the seeds, nuts and leaves of a number of different plants, including:

• Coffea Arabica (used for coffee)
• Camelia sinensis (used for tea)
• Cola acuminate (used as a nut, tea or in soft drinks including cola)
• Theobroma cacao (used in cocoa and chocolate)
• Paulinia cupana (used as guarana in snack bars and energy drinks)

Caffeine is used in a number of different products. The amount of caffeine in these products can vary dramatically, so it’s always best to check the label. The average amounts are listed below.

• 2 tablets of Excedrin-Migraine = 130mg caffeine

The table below shows the amount of caffeine in common food and drinks. The caffeine amounts are averages, so they may change depending on the brand or how the food or drink is made. Check the package label on food and drinks to know how much caffeine they contain.

The amount of caffeine in foods and drinks varies a lot. For coffee and tea, the amount of caffeine depends on:

• The brand
• How it’s prepared
• The type of beans or leaves used
• The way it’s served (for example, as espresso or latte)
• The size of the cup. Not all coffee cups are the same size, even though you think of them as a cup. Check to see how many ounces your cup has, especially if you’re buying a cup of coffee or tea. If you’re making coffee or tea at home, measure to check the size of the cup.

Table 1. The amount of Caffeine used in a number of different products (approximates only)

Some energy drinks contain large amounts of caffeine. For example, a 24-ounce energy drink may have up to 500 milligrams of caffeine. Energy drinks may have a lot of sugar, too, and they may contain ingredients that may be harmful to your baby during pregnancy. Because we don’t know a lot about all the ingredients in energy drinks, it’s best not to have them when you’re pregnant.

The amount of caffeine you get from food and drinks throughout the day adds up. So if you have a cup of coffee in the morning, you may want to limit or give up having other food and drinks during the day that have caffeine.

Effects of caffeine

Caffeine’s main effect is making people feel more awake for a short time. Caffeine aids the release of acid in the stomach, which can result in an upset stomach. Caffeine also helps get rid of fluids from the body (a diuretic).

There is no safe level of drug use. Use of any drug always carries some risk. It’s important to be careful when taking any type of drug.

Caffeine affects everyone differently, based on:

• Size, weight and health
• Whether the person is used to taking it
• Whether other drugs are taken around the same time
• The amount taken

The following effects may be experienced between 5 to 30 minutes after consuming caffeine, and may continue for up to 12 hours:

• Feeling more alert and active
• Restlessness, excitability and dizziness
• Anxiety and irritability
• Dehydration and needing to urinate more often
• Higher body temperature
• Faster breathing and heart rate
• Headache and lack of concentration
• Stomach pains ³

Children and young people who consume energy drinks containing caffeine may also suffer from sleep problems, bed-wetting and anxiety ⁴.

I am trying to become pregnant. Is it true that drinking caffeinated beverages will lower my chance to become pregnant?

Results from studies have been mixed. Some studies have suggested that high levels of caffeine (more than 300mg/day) might make it harder to conceive, but these findings are not proven. Low (less than 200mg/day) to moderate (about 200-300mg/day) caffeine consumption probably does not make it harder for a woman to get pregnant.

How does caffeine affect you and your baby during pregnancy?

Caffeine slightly increases your blood pressure and heart rate and the amount of urine your body makes. Caffeine may cause you to feel jittery, have indigestion or have trouble sleeping. During pregnancy, you may be especially sensitive to caffeine because it may take you longer to clear it from your body than if you weren’t pregnant.

When you have caffeine during pregnancy, it passes through the placenta to your baby. The placenta grows in your uterus (womb) and supplies the baby with food and oxygen through the umbilical cord.

You may have heard that too much caffeine can cause miscarriage (when a baby dies in the womb before 20 weeks of pregnancy). Some studies say this is true, and others don’t. Until scientists know more about how caffeine can affect pregnancy, it’s best to limit the amount you get to 200 milligrams each day. This is about the amount in 2 x 8-ounce cups of coffee or one 12-ounce cup of coffee. Be sure to check the size of your cup to know how much caffeine you’re getting.

Can caffeine cause or make it more likely to have a miscarriage?

There are many studies that have looked at this question. To date, researchers have not reported an association between low levels of caffeine and an increased risk for miscarriage. Most studies on moderate use of caffeine have not found an increased risk of miscarriage. Some studies suggest that taking very high levels (over 800 mg per day) or taking it in high doses with cigarettes or alcohol (both of which are known to increase the risk of miscarriage) may increase the risk for miscarriage.

Will drinking caffeinated beverages during my pregnancy cause birth defects in my baby?

No. Large amounts of caffeine have not been shown to cause an increased chance for birth defects.

Large amounts of caffeine could affect babies in the same way as it does adults. Some reports suggest that children born to mothers who consumed more than 500mg/day were more likely to have faster heart rates, shaking, increased breathing rate, and spend more time awake in the days following birth.

Does drinking caffeinated beverages in pregnancy cause long-term problems in behavior or learning for the baby?

Most studies find no effect on learning or behavior in young school aged children whose mothers consumed caffeine during pregnancy.

Can I drink caffeinated beverages while I breastfeed?

Caffeine passes into breast milk and it suggested that you limit how much you have. If you’re breastfeeding, limit caffeine to no more than two cups of coffee a day. The infant should also be watched for irritability and trouble with sleeping. It’s important to keep drinking water while breastfeeding. Be sure to talk to your health care provider about all your options for breastfeeding.

Is it a problem if the baby’s father consumes a lot of caffeine?

Studies on caffeine and male fertility or sperm quality have not reported consistent findings. In general, exposures that fathers have are unlikely to increase risks to a pregnancy.

Coming down

Some people consume drinks with caffeine so that they can continue working or studying at night. However, the after-effect is that they will feel tired and lethargic the next day.

Long-term effects of taking caffeine

Regular, heavy use of caffeine (such as more than 4 cups of coffee a day) may eventually cause:

• Osteoporosis
• High blood pressure and heart disease
• Heartburn
• Ulcers
• Difficulty sleeping
• Infertility (in men and women)
• Anxiety
• Depression
• Needing to use more to get the same effect
• Dependence on caffeine ⁵

Caffeine Withdrawal

Giving up caffeine after using it for a long time is challenging because the body has to get used to functioning without it. Withdrawal symptoms usually start within 24 hours after the last dose – or even within 6 hours for people who consume a lot of caffeine regularly. The symptoms can last for around 36 hours, or even longer for people who consume a lot.

These symptoms can include:

• Headache
• Tiredness
• Sweating
• Muscle pains
• Anxiety and tension ⁶

Caffeine Overdose

If a large amount of caffeine is consumed it could also cause an overdose. If you experience any of the following effects, call an ambulance straight away by dialing your local emergency number.

• Tremors
• Nausea and vomiting
• Very fast and irregular heart rate
• Confusion and panic attack
• Seizures ⁷

It’s possible to die from having too much caffeine, but this is extremely rare. This would usually only happen if 5–10g of caffeine (or 80 cups of strong coffee) were consumed one after the other ⁵.

In small children, caffeine poisoning can happen if a lower amount, such as around 1g of caffeine (equal to around 12 energy drinks) is consumed one after the other ⁸.

How much caffeine in Excedrin-Migraine

• Excedrin-Migraine: Acetaminophen 250mg + Caffeine 65 mg + Aspirin 250mg
• Excedrin Tension Headache: Acetaminophen 500mg + Caffeine 65 mg
• Excedrin Extra Strength: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg

In comparison a typical 8 ounce (236 ml) serving of brewed coffee contains at least 95-100mg of caffeine.

If you’re pregnant, limit the amount of caffeine you have to 200 milligrams (mg) a day. This is about the same as 2 x 8 ounce (236 ml) of instant coffee.

High levels of caffeine in pregnancy can result in babies having a low birthweight, which can increase the risk of health problems in later life. Too much caffeine can also cause a miscarriage.

Taking Excedrin-Migraine with other painkillers

It’s safe to take Excedrin-Migraine with acetaminophen or codeine.

But don’t take Excedrin-Migraine with similar painkillers like aspirin or naproxen (Aleve) without talking to a doctor.

Excedrin-Migraine, aspirin and naproxen belong to the same group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). If you take them together, Excedrin-Migraine plus aspirin or naproxen may increase the chance of you getting side effects like stomach ache.

Alternatives to Excedrin-Migraine

For treating migraine, an alternative to Excedrin-Migraine is acetaminophen (Tylenol).

For migraine pain, ask your doctor or pharmacist for an alternative if Excedrin-Migraine is not suitable for you. Your health professional may suggest you try:

• Acetaminophen (paracetamol)
• Another medicine from the NSAID family
• A medicine that combines codeine with acetaminophen in the same tablet.

If your pain is severe, your doctor may prescribe you a stronger pain reliever or recommend another treatment, such as triptans or ergots.

Ergotamine and caffeine combination drugs (Migergot, Cafergot) are less effective than triptans. Ergots seem most effective in those whose pain lasts for more than 48 hours. Ergots are most effective when taken soon after migraine symptoms start.

Ergotamine may worsen nausea and vomiting related to your migraines, and it may also lead to medication-overuse headaches.

Dihydroergotamine (D.H.E. 45, Migranal) is an ergot derivative that is more effective and has fewer side effects than ergotamine. It’s also less likely to lead to medication-overuse headaches. It’s available as a nasal spray and in injection form.

Treating migraine without medicine

The following non-medicine treatments may help you to prevent frequent or troublesome migraines — you can use them either instead of, or as well as, medicine treatments:

• physical therapies (e.g., physiotherapy or chiropractic treatment), especially if neck problems are thought to be contributing to your migraines — it’s essential to seek out a therapist with specialist training in this area, however, as there have been very rare reports of stroke after spinal manipulation of the neck
• physical exercise
• relaxation training (e.g., yoga, meditation), which can help manage underlying problems with stress
• cognitive behavioral therapy (CBT), a psychological therapy that teaches you to identify and challenge stress generating thoughts
• acupuncture. If medication is unsuitable, or it doesn’t help to prevent migraines, you may want to consider acupuncture.

Medicines for an acute migraine attack

There’s currently no cure for migraines, although a number of treatments are available to help ease the symptoms.

Most people find that sleeping or lying in a darkened room is the best thing to do when having a migraine attack.

Others find that eating something helps, or they start to feel better once they’ve been sick.

It may take time to work out the best treatment for you. You may need to try different types or combinations of medicines before you find the most effective ones.

Doctors recommend a stepped approach to treatment for acute migraine attack; that is, trying the simplest remedy first. If this fails to manage your pain — as a general rule on 3 consecutive occasions — then you should try the next treatment.

• Step 1. Simple pain relief medicine alone

Most simple pain relief medicines are available to buy over-the-counter in pharmacies and supermarkets.

Many people who have migraines find that over-the-counter painkillers, such as acetaminophen (Tylenol), aspirin and ibuprofen (Advil, Advil-Migraine or Motrin IB), can help to reduce their symptoms.

They tend to be most effective if taken at the first signs of a migraine attack, as this gives them time to absorb into your bloodstream and ease your symptoms.

It’s not advisable to wait until the headache worsens before taking painkillers as it’s often too late for the medication to work. Soluble painkillers (tablets you dissolve in a glass of water) like Advil-Migraine are a good alternative because they’re absorbed quickly by your body.

If you can’t swallow painkillers because of nausea or vomiting, suppositories may be a better option. These are capsules that are inserted into the anus (back passage).

Take pain relief medicine at the first sign of migraine symptoms. As a migraine progresses, your stomach emptying can slow and this can affect the absorption of pain relievers into your bloodstream, making them less effective. This is especially important if you experience nausea and vomiting with migraine.

• Step 2. Simple pain reliever and medicine for nausea and vomiting

If nausea is a problem, or if a pain reliever alone does not relieve your migraine pain, you can take the pain reliever with medicine to treat nausea and vomiting.

Medication for nausea is usually combined with other medications. Frequently prescribed medications are chlorpromazine, metoclopramide (Reglan) or prochlorperazine (Compro).

• Step 3. Anti-migraine medicine: the triptans

If you find you can’t manage your migraines using over-the-counter medicines, your doctor may prescribe something stronger.

Triptans work differently to pain relievers. Triptan medicines are a specific painkiller for migraine headaches. There are a number of different triptans available in the US and you will need to get a prescription from your doctor.

Triptans are thought to work by reversing the changes in the brain that may cause migraine headaches.

They cause the blood vessels around the brain to contract (narrow). This reverses the dilating (widening) of blood vessels that’s believed to be part of the migraine process.

Triptans are available as tablets, injections and nasal sprays.

Common side effects of triptans include:

• warm-sensations
• tightness
• tingling
• flushing
• feelings of heaviness in the face, limbs or chest

Some people also experience nausea, dry mouth and drowsiness. These side effects are usually mild and improve on their own.

As with other painkillers, taking too many triptans can lead to medication overuse headache.

Your doctor will usually recommend having a follow-up appointment once you’ve finished your first course of treatment with triptans. This is so you can discuss their effectiveness and whether you had any side effects.

If the medication was helpful, treatment will usually be continued. If they weren’t effective or caused unpleasant side effects, your doctor may try prescribing a different type of triptan since responses can be highly variable.

• Step 4. Preventive therapy

If you are experiencing two or more severe migraine attacks a month, you could be a candidate for preventive therapy. Preventive therapy is used in addition to treatments for acute attack, not in place of it.

The aim of migraine preventive therapy is to reduce the number of attacks to a manageable level, either because:

• the medicines used to treat attacks don’t control your symptoms adequately, or
• migraine attacks, even though well controlled, are happening far too often, placing you at risk of developing medication overuse headache.

Note that it may take some months for the full effect of preventive therapy to be seen.

In general, medicines used as preventive therapy are more commonly prescribed for the treatment of other conditions (eg, high blood pressure or depression) but have unrelated anti-migraine effects — for example:

• beta-blockers — Propranolol (Deralin), atenolol (Noten, Anselol), metoprolol (Betaloc, Lopressor)
• amitriptyline (Endep).

Other medicines occasionally used to prevent migraines include antiepileptic medicines (especially sodium valproate [Epilim, Valpro] and topiramate [Epiramax, Tamate]), methysergide (Deseril) and botulinum toxin (botox).

Treatment can be complicated and is best managed by a specialist (neurologist).

Excedrin-Migraine Important Information

Do not give Excedrin-Migraine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

Do not take more Excedrin-Migraine than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. Call your doctor at once if you have symptoms such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking Excedrin-Migraine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Excedrin-Migraine Pregnancy Warnings

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity ⁹.

Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women ¹⁰, ¹¹. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women ¹⁰. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women ¹².

One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women ¹³. That study also suggested that acetaminophen does not affect thromboxane production.

The frequency of fetal exposure to aspirin reported in many studies may be underestimated because aspirin (and other salicylates) occur in many over-the-counter preparations and women may fail to recall taking aspirin and over-the-counter drugs ¹⁴.

Increased maternal bleeding can occur during delivery when aspirin is used 1 week prior to and/or during labor and delivery ¹⁵, ¹⁶, ¹⁷. Prolonged gestation and labor have been reported due to aspirin’s inhibition of prostaglandin.

A study ¹⁸ of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy–CLASP) did “not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR.” In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery.

Another study ¹⁹ of low-dose aspirin (follow-up from the Italian Study of Aspirin in Pregnancy) has suggested that “low dose aspirin in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age.”

High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported ¹⁹, ¹⁵. However, a case control study of aspirin use in the first trimester concluded that aspirin “does not increase the risk of congenital heart defects in relation to that of other structural malformations”.

In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.

Aspirin has been assigned to pregnancy category C by the FDA. However, aspirin is considered to be in pregnancy category D by the FDA if full dose aspirin is taken in the third trimester. Use of nonsteroidal anti-inflammatory drugs during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects.

Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations.

Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. During the first two trimesters of pregnancy, the combination of acetaminophen, aspirin, and caffeine should only be given during pregnancy when clearly needed and when benefit outweighs risk. Because of the aspirin component of this combination drug, during the last trimester of pregnancy, this combination product is only recommended for use when there are no alternatives and benefits outweigh risk.

Excedrin-Migraine Breastfeeding Warnings

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose ²⁰.

Aspirin is excreted into human milk in small amounts ²¹, ²². Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics ²³ characterizes aspirin as a drug that has been “associated with significant effects on some nursing infants and should be given to nursing mothers with caution.”

Acetaminophen is excreted into human milk in small concentrations ²¹. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics.

Caffeine is excreted into human milk in small amounts ²⁴. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.

Before taking Excedrin-Migraine Precautions

Do not give Excedrin-Migraine to a child or teenager with a fever, flu symptoms, or chicken pox. Aspirin can cause Reye’s syndrome, a serious and sometimes fatal condition in children.

You should not use Excedrin-Migraine if you are allergic to acetaminophen (Tylenol), aspirin, caffeine, or any NSAIDs (Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others).

Aspirin may cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are taking Excedrin-Migraine.

Ask a doctor or pharmacist if it is safe for you to take Excedrin-Migraine if you have other medical conditions, especially:

• liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
• asthma or seasonal allergies;
• fever with a stiff neck;
• stomach ulcer, stomach or intestinal bleeding, ulcerative colitis;
• a bleeding or blood clotting disorder such as hemophilia;
• kidney disease; or
• if you use medicine to treat glaucoma or prevent blood clots.

If you take Excedrin-Migraine to treat headache pain, seek medical attention if you have:

• a headache so bad you have to lie down;
• a headache that causes vomiting;
• what feels like the worst headache you’ve ever had;
• a headache that seems different from your usual headaches;
• a headache every day;
• a headache after coughing, bending, exercising, or head injury;
• if you have never had migraines diagnosed by a doctor; or
• if you are having your first headache after age 50.

Aspirin may be harmful to an unborn baby’s heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking Excedrin-Migraine.

Aspirin, acetaminophen, and caffeine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using Excedrin-Migraine.

How should I take Excedrin-Migraine?

Use Excedrin-Migraine exactly as directed on the label, or as it has been prescribed by your doctor. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.

Take Excedrin-Migraine with food or milk if it makes your stomach upset.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever lasting longer than 3 days, or any swelling or pain lasting longer than 10 days.

This medication can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Excedrin-Migraine.

If you need surgery, tell the surgeon ahead of time that you are using Excedrin-Migraine. You may need to stop using the medicine for a short time.

Store Excedrin-Migraine at room temperature away from moisture and heat.

What should I avoid?

Avoid drinking alcohol while you are taking Excedrin-Migraine. Alcohol may increase your risk of stomach bleeding while taking aspirin, or liver damage while taking acetaminophen.

Ask a doctor or pharmacist before using any other cough, cold, allergy, pain, menstrual symptom, or fever medication. Acetaminophen (paracetamol) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Aspirin and caffeine are also contained in many combination medicines. Check the label to see if a medicine contains acetaminophen (paracetamol), aspirin, or caffeine.

Avoid taking another NSAID (nonsteroidal anti-inflammatory drug) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking Excedrin-Migraine. They can add to the side effects of the caffeine in the medication.

What happens if I miss a dose?

Since Excedrin-Migraine is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Excedrin-Migraine dosage

Excedrin Migraine Caplets or Geltabs

Active ingredients: Acetaminophen 250 mg + Caffeine 65 mg + Aspirin 250 mg [a Non-Steroidal Anti-Inflammatory Drug (NSAID)]

Inactive Ingredients: benzoic acid, carnauba wax, FD&C blue #1, hydroxypropylcellulose, hypromellose, light mineral oil, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide

Excedrin migraine Migraine uses:

• Treats Migraines
  

Excedrin migraine Migraine Directions of Use:

• Do not use more than directed. If symptoms persist or worsen, ask your doctor
• Drink a full glass of water with each dose
• Adults: Take 2 caplets with a glass of water. Do not take more than 2 caplets in 24 hours, unless directed by a doctor.
• Under 18 years of age: Ask a doctor

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other information:

• store at at room temperature 20°-25°C (68°-77°F)
• close cap tightly after use
• read all product information before using. Keep box for important information

Excedrin-Migraine Warnings

Reye’s syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Medication overuse headache warning

Headaches may worsen if this product is used for 10 or more days per month.

Allergy alert

Acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Ask a doctor or pharmacist before use if:

• you are pregnant or breastfeeding. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• you are taking a prescription drug for diabetes, gout, or arthritis
• you are taking any other drug, or are under a doctor’s care for any serious condition
• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer

Ask a doctor before use if:

• you have never had migraines diagnosed by a health professional
• you have a headache that is different from your usual migraines
• you have the worst headache of your life
• you have fever and stiff neck
• you have headaches beginning after or caused by head injury, exertion, coughing or bending
• you experienced your first headache after the age of 50
• you have daily headaches
• you have a migraine so severe as to require bed rest
• you have liver disease
• stomach bleeding warning applies to you
• you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• you are taking a diuretic
• you have asthma
• you have problems or serious side effects from taking pain relievers or fever reducers
• you have vomiting with your migraine headache

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take:

• more than 2 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or nonprescription NSAlDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• take more or for a longer time than directed

Do NOT use:

• if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Stop use and ask a doctor if:

• an allergic reaction occurs. Seek medical help right away.
• you experience any of the following signs of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
• your migraine is not relieved or worsens after first dose
• ringing in the ears or loss of hearing occurs
• any new or unexpected symptoms occur

These could be signs of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Excedrin-Migraine side effects

General

General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate premenstrual syndrome (PMS).

In general, many side effects noted with aspirin use are dose-related.

Common Excedrin-Migraine side effects may include:

• upset stomach, heartburn;
• depressed mood, feeling anxious or restless; or
• sleep problems (insomnia).

Excedrin-Migraine serious side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Excedrin-Migraine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Excedrin-Migraine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Stop using Excedrin-Migraine and call your doctor at once if you have:

• severe anxiety, agitation, confusion, panic;
• easy bruising or bleeding;
• a light-headed feeling, like you might pass out;
• if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;
• symptoms of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• high potassium–slow heart rate, weak pulse, muscle weakness, tingly feeling; or
• liver problems–nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Feeling confused.
• Feeling very tired or weak.
• Very bad dizziness or passing out.
• Ringing in ears.
• Hearing loss.
• Very bad headache or if headache is not better after the first dose.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Very bad stomach ulcers or bleeding can happen with this drug. Taking it in high doses or for a long time, smoking, or drinking alcohol raises the chance of these side effects. Taking this drug with food will not lower the chance of these effects. Call your doctor or get medical help right away if you get very bad stomach or back pain; black, tarry, or bloody stools; throwing up blood or throw up that looks like coffee grounds; or weight gain or swelling that is not normal.

Other side effects of Excedrin-Migraine

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Belly pain or heartburn.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.

Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.

A 19 year old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Hepatic side effects including hepatotoxicity and hepatitis have been reported.

In alcoholic patients, severe and sometimes fatal dose dependent hepatitis has been reported with acetaminophen use. Hepatotoxicity has been increased during fasting.

Cases of aspirin induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.

Gastrointestinal

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin containing rectal suppositories. One case controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.

Gastrointestinal side effects have been common and have included epigastric distress (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.

In clinical trials of caffeine citrate, five cases of necrotizing enterocolitis were reported among the 46 infants exposed to the caffeine citrate injection.

Gastrointestinal side effects have been rare with the use of acetaminophen, except in alcoholics and after overdose.

Renal

The mechanism of an aspirin induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.

Acetaminophen: Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A case control study of patients with end stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end stage renal disease particularly in patients taking more than two pills per day.

Renal side effects of aspirin have included reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.

Renal side effects have been rare with acetaminophen use and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen related hepatotoxicity.

Hypersensitivity

Hypersensitivity side effects of aspirin have included bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma, and nasal polyps).

Hypersensitivity reactions such as anaphylaxis and fixed drug eruptions have rarely been reported in association with acetaminophen use.

The mechanism of aspirin induced hypersensitivity may be related to an up-regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).

Hematologic

Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.

Rare cases of thrombocytopenia associated with acetaminophen have been reported. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Dermatologic

Dermatologic side effects from the use of aspirin including Stevens-Johnson syndrome and a lichenoid eruption have been reported rarely.

Dermatologic side effects associated with acetaminophen includes the risk of rare but potentially fatal serious skin reactions known as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis and acute generalized exanthematous pustulosis (AGEP). Erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have been reported.

Respiratory

Respiratory side effects including hyperpnea, pulmonary edema, and tachypnea have occurred in patients receiving aspirin.

A case of acetaminophen induced eosinophilic pneumonia has been reported.

Cardiovascular

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.

Cardiovascular side effects of aspirin have been reported rarely and have included salicylate induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity.

Several cases of hypotension have been reported following the administration of acetaminophen.

Metabolic

Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. A case of hypoglycemia has also been reported in a patient on hemodialysis.

Nervous system

Nervous system side effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy, and seizures. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.

Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.

Musculoskeletal

Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.

Endocrine

Endocrine side effects of aspirin use have included hypoglycemia and hyperglycemia.

Ocular

Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.

Oncologic

Oncologic side effects have been reported. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found this beneficial effect.

Other side effects

Other side effect have also been reported. In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.

Reye’s syndrome, although rare, has been associated with aspirin use in children with an acute viral illness. Reye’s syndrome has also been reported even more rarely in adults.

Prolonged labor and pregnancy, decreased infant birth weight and stillborn births, antepartum and postpartum bleeding have occurred due to aspirin use by women during the third trimester of pregnancy.

Reye’s syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Excedrin-Migraine overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. This is a free and confidential service. All local poison control centers in the United States use this national number. You should call if you have any questions about poisoning or poison prevention. It does NOT need to be an emergency. You can call for any reason, 24 hours a day, 7 days a week.

1. Upfal J. (2006) The Australian Drug Guide (7th Ed.) Melbourne: Black Inc.
2. Food Regulation Standing Committee, Caffeine Working Group. (2013). The regulation of caffeine in foods.
3. Upfal, J. (2006). The Australian drug guide. (7th ed.). Melbourne: Black Inc.
4. Seifer, S., Schaechter, J., Hershorin, E. & Lepshultz, S. (2011). Health effects of energy drinks on children, adolescents, and young adults. Pediatrics, 127(3). 511–528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065144/
5. Brands, B., Sproule, B., & Marshman, J. (Eds.). (1998). Drugs & drug abuse (3rd ed.). Ontario: Addiction Research Foundation.
6. American Psychiatric Association. (2013). Diagnostic and Statistical Manual of Mental Disorders. (5th ed). Washington: American Psychiatric Publishing.
7. NPS Medicinewise. (2013). https://www.nps.org.au/news#Information
8. Arria, A., Calderia, K., Kasperski, S., O’Grady, K., Vincent, K., Griffiths, R. & Wish, E. (2010). Increased alcohol consumption, nonmedical prescription drug use, and illicit drug use are associated with energy drink consumption among college students. Journal of Addiction Medicine, 4(2). 74–80. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923814/
9. Byer AJ, Traylor TR, Semmer JR “Acetaminophen overdose in the third trimester of pregnancy.” JAMA 247 (1982): 3114-5
10. Rayburn W, Shukla U, Stetson P, Piehl E “Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women.” Am J Obstet Gynecol 155 (1986): 1353-6
11. Galinsky RE, Levy G “Absorption and metabolism of acetaminophen shortly before parturition.” Drug Intell Clin Pharm 18 (1984): 977-9
12. Beaulac-Baillargeon L, Rocheleau S “Paracetamol pharmacokinetics during the first trimester of human pregnancy.” Eur J Clin Pharmacol 46 (1994): 451-4
13. O’Brien WF, Krammer J, O’Leary TD, Mastrogiannis DS “The effect of acetaminophen on prostacyclin production in pregnant women.” Am J Obstet Gynecol 168 (1993): 1164-9
14. Briggs GG, Freeman RK, Yaffe SJ.. “Drugs in Pregnancy and Lactation. 5th ed.” Baltimore, MD: Williams & Wilkins;1998
15. Rudolph AM “Effects of aspirin and acetaminophen in pregnancy and in the newborn.” Arch Intern Med 141 (1981): 358-63
16. Karlowicz MG, White LE “Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion.” Clin Pediatr (Phila) 32 (1993): 740-3
17. Schoenfeld A, Bar Y, Merlob P, Ovadia Y “NSAIDs: maternal and fetal considerations.” Am J Reprod Immunol 28 (1992): 141-7
18. “Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women.” Lancet 343 (1994): 619-29
19. Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C “Follow-up of children in the italian study of aspirin in pregnancy.” Lancet 343 (1994): 1235
20. Committee on Drugs, 1992 to 1993 “The transfer of drugs and other chemicals into human milk.” Pediatrics 93 (1994): 137-50
21. Matheson I, Lunde PK, Notarianni L “Infant rash caused by paracetamol in breast milk.” Pediatrics 76 (1985): 651-2
22. Erickson SH, Oppenheim GL “Aspirin in breast milk.” J Fam Pract 8 (1979): 189-90
23. Roberts RJ, Blumer JL, Gorman RL, et al “American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk.” Pediatrics 84 (1989): 924-36
24. Berlin CM Jr, Denson HM, Daniel CH, Ward RM “Disposition of dietary caffeine in milk, saliva, and plasma of lactating women.” Pediatrics 73 (1984): 59-63

What is Orajel

Orajel contains an active ingredient called Benzocaine, which is a local anesthetic (numbing medication) that acts by preventing transmission of impulses along nerve fibers and at nerve endings. Orajel (Benzocaine) works by blocking nerve signals in your body. Orajel (Benzocaine) is used to reduce pain or discomfort from a variety of conditions such as minor skin irritations, sore throats, canker sores, irritation of the mouth and gums, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body.

Health care professionals often use sprays containing benzocaine to numb the mucous membranes inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting instruments down the throat to view internal organs, inserting breathing tubes, and feeding tubes or speculum, however, benzocaine products are not U.S. Food and Drug Administration (FDA)-approved for these uses.

Benzocaine products are available as gels, sprays, ointments, solutions, and lozenges.

Benzocaine products are marketed under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine, and Topex, as well as store brands and generics.

What does Orajel do?

Benzocaine is a local anesthetic commonly used as a topical pain reliever. Orajel (Benzocaine) is an ester of paraaminobenzoic acid, with anesthetic activity. Benzocaine binds to the sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited, thereby blocking the initiation and conduction of nerve impulses along nerve fibers and at nerve endings. The action of benzocaine is completely reversible.

Is Orajel safe for babies?

No. See the U.S. Food and Drug Administration (FDA) warnings on the use of Orajel (Benzocaine) in babies. Furthermore, American Academy of Pediatrics is against the use of the over-the-counter (OTC) topical benzocaine for teething pain in pediatric patients ¹. Due to the adverse side effect such as methemoglobinemia caused by the benzocaine, the Orajel manufacturer’s have decided to discontinue the distribution and sale of Orajel™ teething products containing benzocaine. “The discontinuation is effective immediately and includes Orajel™ Medicated Teething Gel, Orajel™ Medicated Nighttime Teething Gel, Orajel™ Medicated Daytime & Nighttime Teething Twin Pack and Orajel™ Medicated Teething Swabs. We are not discontinuing other Orajel™ products, which represent the majority of our Orajel™ offering” ².

What is Methemoglobinemia?

Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin is produced ⁷. Hemoglobin is the protein in red blood cells (RBCs) that carries and distributes oxygen to the body. Methemoglobin is a form of hemoglobin. With methemoglobinemia, the hemoglobin can carry oxygen, but is not able to release it effectively to body tissues.

Danger signs and symptoms of methemoglobinemia include:

• pale, gray, or blue-colored skin, lips and nail beds
• shortness of breath
• fatigue
• confusion
• headache
• light-headedness
• rapid heart rate

Symptoms can occur within minutes to hours after benzocaine use. They can occur after using the drug for the first time, as well as after several uses.

If your child has any of these symptoms after using benzocaine, stop using the product and seek medical help immediately by calling your local emergency services number for an ambulance.

Methemoglobinemia caused by benzocaine may require treatment with medications and admission to a hospital. Serious cases should be treated right away. If left untreated or if treatment is delayed, methemoglobinemia may cause permanent injury to the brain and body tissues, and even death, from the insufficient amount of oxygen in the blood.

Complications of methemoglobinemia include ⁸:

• Shock
• Seizures
• Death

Methemoglobinemia Exams and Tests ⁸

A baby with this condition will have a bluish skin color (cyanosis). The health care provider will perform blood tests to diagnose the condition. Tests may include:

• Checking the oxygen level in the blood (pulse oximetry)
• Blood test to check levels of gases in the blood (arterial blood gas analysis)

Methemoglobinemia Treatment ⁸

A medicine called methylene blue is used to treat severe methemoglobinemia. Methylene blue may be unsafe in people who have or may be at risk for a blood disease called glucose-6-phosphate dehydrogenase (G6PD). They should not take this medicine. If you or your child has glucose-6-phosphate dehydrogenase (G6PD), always tell your provider before getting treatment.

Ascorbic acid may also be used to reduce the level of methemoglobin.

Alternative treatments include hyperbaric oxygen therapy, red blood cell transfusion and exchange transfusions.

In most cases of mild acquired methemoglobinemia, no treatment is needed. But you should avoid the medicine or chemical that caused the problem. Severe cases may need a blood transfusion.

Outlook (Prognosis)

People with acquired methemoglobinemia often do very well once the drug, food, or chemical that caused the problem is identified and avoided ⁸.

What is the recommendations for treating teething pain in babies?

The American Academy of Pediatrics’ recommendations ⁴ for treating teething pain in 4 to 7 months old babies

Teething usually starts during 4 to 7 months. The two front teeth (central incisors), either upper or lower, usually appear first, followed by the opposite front teeth. The first molars come in next, followed by the canines or eyeteeth.

The timing of teething

There is great variability in the timing of teething. If your child doesn’t show any teeth until later than this age period, don’t worry. The timing may be determined by heredity, and it doesn’t mean that anything is wrong.

How to ease your baby’s discomfort

Teething occasionally may cause mild irritability, crying, a low-grade temperature (but not over 101 ° Fahrenheit or 38.3 ° Celsius), excessive drooling, and a desire to chew on something hard. More often, the gums around the new teeth will swell and be tender. Try gently rubbing or massaging the gums with one of your fingers. Teething rings are helpful, too, but they should be made of firm rubber. (The teethers that you freeze tend to get too hard and can cause more harm than good.) Pain relievers and medications that you rub on the gums are not necessary or useful since they wash out of the baby’s mouth within minutes. Some medication you rub on your child’s gums can even be harmful if too much is used and the child swallows an excessive amount. Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine. Belladonna and benzocaine are marketed to numb your child’s pain, but the FDA (see FDA’s warnings above) has issued warnings against both due to potential side effects.​ If your child seems particularly miserable or has a fever higher than 101 degrees Fahrenheit (38.3 degrees Celsius), it’s probably not because she’s teething, and you should consult your pediatrician.

How should you clean the new teeth?

Simply brush them with a soft child’s toothbrush when you first start seeing her teeth. To prevent cavities, never let your baby fall asleep with a bottle, either at nap time or at night. By avoiding this situation, you’ll keep milk from pooling around the teeth and creating a breeding ground for tooth decay.

Important Information Before Using Orajel

Orajel (Benzocaine) used in the mouth or throat may cause methemoglobinemia, a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. Do not use this medicine if you have ever had methemoglobinemia.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

• Do not use this medicine on a child younger than 2 years old without medical advice.

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. Use the smallest amount of this medication needed.

Ask a doctor or pharmacist if it is safe for you to use Orajel (Benzocaine) if you have:

• asthma, bronchitis, emphysema, or other breathing disorder;
• heart disease;
• a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or
• if you smoke.

It is not known whether Orajel (Benzocaine) topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether Orajel (Benzocaine) topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Benzocaine Precautions

• Benzocaine topical is considered contraindicated in patients with congenital or idiopathic methemoglobinemia.
• Benzocaine should not be used in infants less than 12 months of age who are receiving treatment with methemoglobin- inducing agents.
• Benzocaine topical is for external use only, and is not intended to be used in or near the eyes.
• Benzocaine crystals may appear as a white precipitate following topical application.
• Do not apply in large quantities or over large, raw, or blistered areas,
• Benzocaine topical is not intended for use on deep or puncture wounds, or serious burns.
• Instruct patients to avoid eating for approximately 1 hour following topical application to oral mucosa.
• Safety and effectiveness of benzocaine sore throat lozenges have not been established in children less than 5 years of age.

How to use Orajel

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of Orajel (Benzocaine), or cover treated skin areas with a bandage or plastic wrap without medical advice.

Your body may absorb more of this medicine if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Do not use Orajel (Benzocaine) to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

• To treat minor skin conditions, apply a thin layer of Orajel (Benzocaine) to the affected area.
• If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.
• To treat hemorrhoids, apply the medication up to 6 times per day. After cleansing area with soap and water, apply externally to affected area(s) as needed up to 6 times a day. Wash your hands before and after inserting a rectal suppository. Do not take a rectal suppository by mouth. It is for use only in your rectum. Try to empty your bowel and bladder just before using the benzocaine suppository. Remove the wrapper before inserting the suppository. Avoid handling the suppository too long or it will melt in your hands. Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first. For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in. Avoid using the bathroom for at least an hour after using the suppository.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using Orajel (Benzocaine). Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?

Since Orajel (Benzocaine) is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Orajel (Benzocaine) applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while using Orajel?

Avoid eating within 1 hour after using Orajel (Benzocaine) on your gums or inside your mouth.

Orajel (Benzocaine) is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Orajel side effects

Orajel (Benzocaine) used in the mouth or throat may cause a rare but life-threatening condition called methemoglobinemia. In this condition, the amount of oxygen in your blood stream becomes dangerously low. This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using Orajel (Benzocaine) in the mouth or throat.

GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• headache, tired feeling, confusion;
• fast heart rate;
• feeling light-headed or short of breath; and
• pale, blue, or gray appearance of your skin, lips, or fingernails.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Orajel (Benzocaine) and call your doctor at once if you have:

• severe burning, stinging, or sensitivity where the medicine is applied;
• swelling, warmth, or redness; or
• oozing, blistering, or any signs of infection.

Common side effects may include:

• mild stinging, burning, or itching where the medicine is applied;
• skin tenderness or redness; or
• dry white flakes where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch/default.htm) or by phone (1-800-332-1088).

Along with its needed effects, benzocaine topical (the active ingredient contained in Orajel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking benzocaine topical:
Incidence not known

• Headache
• High fever
• Nausea
• Vomiting
• Worsening of pain, redness, swelling, or irritation in or around the mouth

Side effects apply to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

• Dermatologic side effects have included contact dermatitis and urticaria.

Local

• Local side effects have included burning and stinging.

Other

• Other side effects have included edema.

Cardiovascular

• Cardiovascular side effects have included angioedema.

Hematologic

• Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.

1. Guideline on infant oral health care. American Academy of Pediatric Dentistry. Clinical Affairs Committee–Infant Oral Health Subcommittee. Pediatr Dent. 2012 Sep-Oct; 34(5):e148-52. http://www.aapd.org/publications/
2. http://www.orajel.com/
3. Risk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics. https://www.fda.gov/Drugs/DrugSafety/ucm608265.htm
4. Teething: 4 to 7 Months. https://www.healthychildren.org/English/ages-stages/baby/teething-tooth-care/pages/Teething-4-to-7-Months.aspx
5. FDA confirms elevated levels of belladonna in certain homeopathic teething products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm
6. https://www.ada.org/~/media/ADA/Publications/Files/ADA_PatientSmart_Mouth_Sores.pdf?la=en
7. Hartman NR, Mao JJ, Zhou H, Boyne MT, Wasserman AM, Taylor K, Racoosin JA, Patel V, Colatsky T. More methemoglobin is produced by benzocaine treatment than lidocaine treatment in human in vitro systems. Regul Toxicol Pharmacol 2014; 70:182-8.
8. Methemoglobinemia. https://medlineplus.gov/ency/article/000562.htm

What is Afrin

Afrin nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Afrin is also used to relieve sinus congestion and pressure. Afrin active ingredient is called Oxymetazoline hydrochloride. Afrin (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Afrin (Oxymetazoline) nasal spray carefully and under adult supervision.

Afrin (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Afrin (Oxymetazoline) is available without a prescription.

Afrin Nasal Spray

• Active ingredients: Oxymetazoline hydrochloride 0.05%
• Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Afrin Pump Mist

• Active ingredients: Oxymetazoline hydrochloride 0.05%
• Inactive ingredients: benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Afrin Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes so you can breathe more freely

Afrin (Oxymetazoline) is available in the following dosage forms:

• Nasal Pump Mist
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use Afrin Pump Mist:

• Shake well before use. Hold white tabs, press grooved area of cap firmly and turn counter clockwise. Before using the first time, prime metered pump by
  depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use. Secure cap after use.

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

How does Afrin work?

Afrin (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Afrin (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Before using Afrin – Precautions

• tell your doctor and pharmacist if you are allergic to Afrin (Oxymetazoline), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• Afrin (Oxymetazoline) is contra-indicated with monoamine oxidase inhibitor (MAOI) medicine used for the treatment of depression
• tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or thyroid or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Afrin (Oxymetazoline) nasal spray, call your doctor.

Pediatric patients

Children may be especially sensitive to the effects of Afrin (Oxymetazoline). This may increase the chance of side effects during treatment.

Geriatric patients

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of Afrin (Oxymetazoline) in the elderly.

Afrin and Pregnancy

Safe use of Afrin (Oxymetazoline) during pregnancy has not been established. Oxymetazoline hydrochloride ophthalmic or nasal solutions should be used during pregnancy only when instructed by a clinician ¹.

• The effects of repeated use of Afrin (Oxymetazoline) nasal spray in a 20-yr-old woman, with uncomplicated pregnancy, resulting in nonreactive nonstress test, late decelerations and fetal heart rate abnormalities, were reported ².
• This investigation ³ studied the effects of Afrin (Oxymetazoline) on the maternal and fetal circulations. Twelve healthy gravid patients in the third trimester (27-39 weeks) underwent flow velocity measurements by the same sonographer using a pulsed Doppler system (ATL Ultramark 4 machine). Maternal and fetal indices were recorded 15 min before dosing, immediately thereafter, and at 15 min intervals during the first 2 hr after the drug was given. No significant changes were found in either the maternal blood pressures or pulse rates. Blood flow velocities did not change significantly from baseline for the uterine arcuate artery, fetal aorta, or umbilical artery circulations. In no case did absolute blood flow velocity decrease significantly or systolic/diastolic ratios elevate to worrisome values. For uncomplicated pregnancies, it was concluded there are no significant acute changes in the maternal and fetal circulations after a single dose of intranasal Afrin (Oxymetazoline) ³.

Afrin and Breastfeeding

Although no information exists on the use of Afrin (Oxymetazoline) specifically during breastfeeding, very little should reach the infant through breastmilk because of the local administration and limited absorption into the maternal bloodstream ⁴. It is recommended over oral systemic decongestants such as pseudoephedrine during breastfeeding ⁴. Topical use on the face is unlikely to present a risk to the nursing infant. However, weigh the potential benefits against the potential risks before taking Afrin (Oxymetazoline) while breastfeeding.

• Maternal Drug Levels. Relevant published information was not found.
• Infant Drug Levels. Relevant published information was not found.
• Effects in Breastfed Infants: Relevant published information was not found.
• Effects on Lactation and Breastmilk: Relevant published information was not found.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Afrin (Oxymetazoline), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Afrin (Oxymetazoline) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Fentanyl Citrate
• Furazolidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dryness in nose or
• High blood pressure or
• Tachycardia (fast heart rate) or
• Trouble urinating from an enlarged prostate—May make these conditions worse.

How should Afrin be used?

Afrin (Oxymetazoline) nasal spray comes as a solution (liquid) to spray into your nose. Afrin (Oxymetazoline) nasal spray is usually used every 10 to 12 hours as needed, but not more often than twice in a 24-hour period. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Afrin (Oxymetazoline) nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or directed on the label.

If you use Afrin (Oxymetazoline) nasal spray for more often or for longer than the recommended period of time, your congestion may get worse or may improve but come back. Do not use Afrin (Oxymetazoline) nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using Afrin (Oxymetazoline) and call your doctor.

Afrin (Oxymetazoline) nasal spray is only for use in the nose. Do not swallow the medication.

To prevent the spread of infection, do not share your spray dispenser with anyone else. Rinse the tip of the dispenser with hot water or wipe it clean after you use it.

Follow the directions for using the Afrin (Oxymetazoline) nasal spray that appear on the package label. If you are using a product that comes in a pump dispenser, press down on the rim several times before using your first dose to prime the pump, according to the directions on the label. When you are ready to use the spray, hold your head upright without tilting and place the tip of the bottle in your nostril. For the Afrin (Oxymetazoline) nasal spray, squeeze the bottle quickly and firmly. For products that come in a pump dispenser, press down on the rim with a firm, even stroke and breathe in deeply.

To use Afrin pump mist:

• Shake well before use.
• Hold white tabs, press grooved area of cap firmly and turn counter clockwise.
• Before using the first time, prime metered pump by depressing pump firmly several times.
• To spray, hold bottle with thumb at base and nozzle between first and second fingers.
• Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
• Wipe nozzle clean after use.
• Secure cap after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

Afrin Dosing

The dose of Afrin (Oxymetazoline) will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Afrin (Oxymetazoline) that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Afrin (Oxymetazoline) nasal dosage form (pump mist or nasal spray):

• For nasal congestion or stuffiness:
  • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  • Children up to 6 years of age—Use and dose must be determined by your doctor.

What if I forget to take it?

If you miss a dose of Afrin (Oxymetazoline), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Afrin Nasal Spray

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: benzalkonium chloride solution, edetate disodium, polyethylene glycol, povidone, propylene glycol, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Other information

• store between 20° to 25°C (68° to 77°F)
• retain card for future reference on full labeling
• SAFETY SEALED: Do not use if “Afrin Security Seal” imprinted on bottle is broken or missing

Afrin Nasal Spray Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes so you can breathe more freely

Afrin Nasal Spray Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Afrin Nasal Spray Directions of Use

To use Afrin Nasal Spray:

• Push firmly down on cap and turn counter clockwise.
• Place tip of nozzle just past nasal opening (approximately 1/8″)
• To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying.
• Sniff deeply.
• Wipe nozzle clean after use
• Secure cap after use.

Afrin Nasal Spray Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Afrin Pump Mist

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: benzalkonium chloride solution, benzyl alcohol, edetate disodium, flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyethylene glycol, povidone, purified water, sodium phosphate dibasic, sodium phosphate monobasic

Other information

• store between 20° to 25°C (68° to 77°F)
• retain card for future reference on full labeling
• SAFETY SEALED: Do not use if “Afrin Security Seal” imprinted on bottle is broken or missing

Afrin Pump Mist Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes so you can breathe more freely

Afrin Pump Mist Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Afrin Pump Mist Directions of Use

To use pump mist:

• Shake well before use.
• Hold white tabs, press grooved area of cap firmly and turn counter clockwise.
• Before using the first time, prime metered pump by depressing pump firmly several times.
• To spray, hold bottle with thumb at base and nozzle between first and second fingers.
• Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply.
• Wipe nozzle clean after use.
• Secure cap after use.

Afrin Pump Mist Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Afrin side effects

Afrin (Oxymetazoline) may cause side effects.

Common side effects

• Transient burning, stinging, increased nasal discharge
• Dryness inside the nose
• Sneezing
• Difficulty falling asleep or staying asleep
• Rebound congestion with prolonged use (4-5 days)
• Rebound congestion is associated with overuse and may take several weeks to reverse

Tell your doctor if any of these symptoms are severe or do not go away.

Uncommon side effects

• Hypertension
• Nausea
• Nervousness
• Dizziness
• Drowsiness
• Insomnia
• Headache
• CNS (central nervous system) effects are more common in children

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast heartbeat
• slow heartbeat

Oxymetazoline nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Human Toxicity Reports

Intranasal use of oxymetazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, or reflex bradycardia ¹.

A total of 307 patients with acute rhinitis entered a study to compare the difference between oxymetazoline with preservative and oxymetazoline without preservative. The treatment with oxymetazoline with preservative and oxymetazoline without preservative and xylometazoline with preservative was evaluated. This randomized, double-blind, multi-centered, tolerance study confirmed that the local sympathomimetics oxymetazoline and xylometazoline are well tolerated in the treatment of acute rhinitis. When evaluated according to the parameters “feeling of dryness in nasal mucosa” and “burning sensation”, a 0.05% spray, which contains the active agent oxymetazoline without preservatives, proved to be considerably superior to preparations containing the preservative benzalkonium chloride ⁵.

A case report of an abrupt withdrawal in a healthy man of oxymetazoline nasal spray precipitated a prolonged panic disorder that required hospitalization with extensive evaluations ⁶.

Excessive dosage and/or prolonged or too frequent intranasal use of oxymetazoline may irritate nasal mucosa and especially in children, cause adverse systemic effects. Excessive dosage or inadvertent ingestion in children may cause profound CNS (central nervous system) depression, possibly necessitating intensive supportive care ¹. CNS depression, shock-like hypotension, and coma have occurred following overdosage of naphazoline and tetrahydrozoline; the possibility that this may occur with oxymetazoline should be considered ¹.

In this case report, oxymetazoline nasal spray 0.025% was administered to a 2-year-old patient during general anesthesia for nasal endoscopy. Severe hypertension with reflex bradycardia progressed to sinus arrest and was successfully treated with atropine and cardiopulmonary resuscitation ⁷.

A patient prescribed oxymetazoline hydrochloride nasal drops presented with recurrent ventricular tachycardia of fascicular origin ⁸. Cardiac ultrasound showed a calcified lesion, presumably a fibroma arising from the interventricular septum. Fascicular tachycardia related to the lesion and provoked by the use of a sympathomimetic agent is postulated ⁸.

A case of chronic use of nasal oxymetazoline associated with thunderclap headache due to reversible segmental intracranial vasoconstriction is reported ⁹. The patient had been using a nasal spray that contains oxymetazoline, regularly for the previous 6 months ⁹. Although she was using the medication at recommended daily dosages (2–3 sprays twice daily), she was using it consistently. Two weeks before presentation she had noticed a pattern of headache starting 20 minutes after use of the nasal spray. The event had occurred immediately after its use. Thunderclap headache is a hyperacute, severe headache that is so named because of its sudden onset. It often heralds a serious intracranial vascular event such as subarachnoid hemorrhage, cerebral venous sinus thrombosis or pituitary apoplexy. However, it may also occur spontaneously or in the setting of cerebral vasoconstriction. Narcotic analgesics reduced the pain, but the nausea and vomiting responded to ondansetron only. The patient had no improvement in her headache with nimodipine, a calcium-channel antagonist that causes dilatation of arterial smooth muscle. Two weeks after discharge the headache had nearly resolved. A repeat angiogram at 6 weeks showed complete resolution of most areas of arterial narrowing ⁹. This case report illustrates that oxymetazoline can cause reversible segmental cerebral vasoconstriction, resulting in thunderclap headache.

A case report of 43-year-old woman who was evaluated for sequential bilateral vision loss following the use of oxymetazoline nasal spray. Thorough investigation of possible causes causing the bilateral anterior ischemic optic neuropathy was negative. The patient had several predisposing risk factors for ischemic optic neuropathy, including diabetes mellitus, hypertension, and crowded optic nerve heads. Before each acute optic neuropathy, the patient used two to three puffs of oxymetazoline nasal spray ¹⁰.

A case report of a young, otherwise healthy man presented with an acute retinal artery obstruction following excessive use of oxymethazolone hydrochloride 0.5% nasal spray ¹¹. Platelet coagulation studies indicated a platelet aggregation hypersensitivity to adenosine diphosphate and epinephrine. A predisposition for sympathomimetic drug-induced platelet fibrin embolus formation appears to be the cause of the retinal artery obstruction in this case ¹¹.

A case is presented in which a 73-yr-old man who was using Afrin (oxymetazoline hydrochloride) nasal spray several times daily, for the treatment of nasal congestion, developed bradycardia, hypotension and dizziness associated with oxymetazoline hydrochloride ¹².

1. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824
2. Baxi LV et al; J Obstet Gynecol 153 (Dec): 799 -800, 1985
3. Rayburn WF, et al; Obstet Gynecol 76 (2): 180-2, 1990
4. Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16:294 https://www.ncbi.nlm.nih.gov/pubmed/11155604
5. Dorn M et al; HNO 51 (10): 794-9, 2003 https://www.ncbi.nlm.nih.gov/pubmed/14523532
6. Saadah HA; J Clin Psychiarty 48 (7): 293, 1987 https://www.ncbi.nlm.nih.gov/pubmed/3597333
7. Thrush DN; J Clin Anesth 7 (6): 5112-4; 1995 https://www.ncbi.nlm.nih.gov/pubmed/8534470
8. Khan A, Dewhurst N; Br J Clin Pract 51 (3): 192-3, 1997 https://www.ncbi.nlm.nih.gov/pubmed/9293069
9. Loewen AHS, Hudon ME, Hill MD. Thunderclap headache and reversible segmental cerebral vasoconstriction associated with use of oxymetazoline nasal spray. CMAJ : Canadian Medical Association Journal. 2004;171(6):593-594. doi:10.1503/cmaj.1040631. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC516194/
10. Fivhas GD, Newman NJ; Am J Ophthalmol 127 (1): 104-6, 1999 https://www.ncbi.nlm.nih.gov/pubmed/9933016
11. Magargal LE et al; Ann Ophthalmol 17 (8): 500-1,1985 https://www.ncbi.nlm.nih.gov/pubmed/2413795
12. Glazener F et al; N Engl J Med 309 (Sep 22): 731, 1983

What is Zicam

Zicam nasal spray is used for the temporary relief of nasal congestion associated with acute and chronic rhinitis or stuffiness caused by hay fever or other allergies and common colds. Zicam is also used to relieve sinus congestion and pressure. Zicam active ingredient is called Oxymetazoline hydrochloride. Zicam (Oxymetazoline) nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should only use Zicam (Oxymetazoline) nasal spray carefully and under adult supervision.

Zicam (Oxymetazoline) may also be used for other conditions as determined by your doctor.

Zicam (Oxymetazoline) is available without a prescription.

Zicam Uses

• Temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• Temporarily relieves sinus congestion and pressure
• Helps clear nasal passages
• Shrinks swollen membranes

Zicam (Oxymetazoline) is available in the following dosage forms:

• Nasal Solution
• Nasal Spray

Directions of use

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

To use pump:

• to open, hold the actuator to squeeze and turn cap
• hold with thumb at bottom of bottle and nozzle between fingers
• before using the first time, prime pump by depressing several times
• place tip of nozzle just past nasal opening (approximately 1/8″)
• pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
• wipe nozzle clean after use
• to close, turn cap until it ‘clicks’

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

How much zinc is in Zicam?

Zicam (Oxymetazoline) nasal spray does not contain any zinc.

Active ingredients: Oxymetazoline hydrochloride 0.05%

Inactive ingredients: aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

How does Zicam work?

Zicam (Oxymetazoline) is a selective α_2A-adrenergic receptor agonist a sympathomimetic amine in a class of medications called nasal decongestants. It is used as a topical vasoconstrictor. Zicam (Oxymetazoline) works by narrowing the blood vessels (vasoconstriction) in the nasal passages, thus decreasing nasal blood flow and nasal congestion.

Before using Zicam – Precautions

• tell your doctor and pharmacist if you are allergic to Zicam (Oxymetazoline), or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• Zicam (Oxymetazoline) is contra-indicated with monoamine oxidase inhibitor (MAOI) medicine used for the treatment of depression
• tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or thyroid or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using Zicam (Oxymetazoline) nasal spray, call your doctor.

Pediatric patients

Children may be especially sensitive to the effects of Zicam (Oxymetazoline). This may increase the chance of side effects during treatment.

Geriatric patients

Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of Zicam (Oxymetazoline) in the elderly.

Zicam and Pregnancy

Safe use of Zicam (Oxymetazoline) during pregnancy has not been established. Oxymetazoline hydrochloride ophthalmic or nasal solutions should be used during pregnancy only when instructed by a clinician ¹.

• The effects of repeated use of Zicam (Oxymetazoline) nasal spray in a 20-yr-old woman, with uncomplicated pregnancy, resulting in nonreactive nonstress test, late decelerations and fetal heart rate abnormalities, were reported ².
• This investigation ³ studied the effects of Zicam (Oxymetazoline) on the maternal and fetal circulations. Twelve healthy gravid patients in the third trimester (27-39 weeks) underwent flow velocity measurements by the same sonographer using a pulsed Doppler system (ATL Ultramark 4 machine). Maternal and fetal indices were recorded 15 min before dosing, immediately thereafter, and at 15 min intervals during the first 2 hr after the drug was given. No significant changes were found in either the maternal blood pressures or pulse rates. Blood flow velocities did not change significantly from baseline for the uterine arcuate artery, fetal aorta, or umbilical artery circulations. In no case did absolute blood flow velocity decrease significantly or systolic/diastolic ratios elevate to worrisome values. For uncomplicated pregnancies, it was concluded there are no significant acute changes in the maternal and fetal circulations after a single dose of intranasal Zicam (Oxymetazoline) ³.

Zicam and Breastfeeding

Although no information exists on the use of Zicam (Oxymetazoline) specifically during breastfeeding, very little should reach the infant through breastmilk because of the local administration and limited absorption into the maternal bloodstream ⁴. It is recommended over oral systemic decongestants such as pseudoephedrine during breastfeeding ⁴. Topical use on the face is unlikely to present a risk to the nursing infant. However, weigh the potential benefits against the potential risks before taking Zicam (Oxymetazoline) while breastfeeding.

• Maternal Drug Levels. Relevant published information was not found.
• Infant Drug Levels. Relevant published information was not found.
• Effects in Breastfed Infants: Relevant published information was not found.
• Effects on Lactation and Breastmilk: Relevant published information was not found.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking Zicam (Oxymetazoline), it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Zicam (Oxymetazoline) with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Fentanyl Citrate
• Furazolidone
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Dryness in nose or
• High blood pressure or
• Tachycardia (fast heart rate) or
• Trouble urinating from an enlarged prostate—May make these conditions worse.

How should Zicam be used?

Zicam (Oxymetazoline) nasal spray comes as a solution (liquid) to spray into your nose. Zicam (Oxymetazoline) nasal spray is usually used every 10 to 12 hours as needed, but not more often than twice in a 24-hour period. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use Zicam (Oxymetazoline) nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or directed on the label.

If you use Zicam (Oxymetazoline) nasal spray for more often or for longer than the recommended period of time, your congestion may get worse or may improve but come back. Do not use Zicam (Oxymetazoline) nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using Zicam (Oxymetazoline) and call your doctor.

Zicam (Oxymetazoline) nasal spray is only for use in the nose. Do not swallow the medication.

To prevent the spread of infection, do not share your spray dispenser with anyone else. Rinse the tip of the dispenser with hot water or wipe it clean after you use it.

Follow the directions for using the Zicam (Oxymetazoline) nasal spray that appear on the package label. If you are using a product that comes in a pump dispenser, press down on the rim several times before using your first dose to prime the pump, according to the directions on the label. When you are ready to use the spray, hold your head upright without tilting and place the tip of the bottle in your nostril. For the Zicam (Oxymetazoline) nasal spray, squeeze the bottle quickly and firmly. For products that come in a pump dispenser, press down on the rim with a firm, even stroke and breathe in deeply.

How to use the Zicam nose spray

• Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. If needed, blow the nose gently again and repeat the spray process until the total dose is used.
• Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

To use the Zicam nose drops

• Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose.
• Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use.
• To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better.

Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects.

Zicam Dosing

The dose of Zicam (Oxymetazoline) will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of Zicam (Oxymetazoline) that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For Zicam (Oxymetazoline) nasal dosage form (nose drops or spray):

• For nasal congestion or stuffiness:
  • Adults and children 6 years of age and older—Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours.
  • Children up to 6 years of age—Use and dose must be determined by your doctor.

What if I forget to take it?

If you miss a dose of Zicam (Oxymetazoline), take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Zicam Nasal Spray

Active ingredients: Oxymetazoline hydrochloride 0.05%

Purpose: Nasal decongestant

Inactive ingredients: aloe barbadensis gel, benzalkonium chloride, benzyl alcohol, disodium EDTA, disodium phosphate, glycerin, hydroxyethylcellulose, hydroxylated lecithin, monosodium phosphate, purified water

Other information

• store between 15-29°C (59-84°F)
• retain carton for future reference on full labeling

Zicam Nasal Spray Uses

• temporarily relieves nasal congestion due to:
  • the common cold
  • hay fever
  • upper respiratory allergies
• temporarily relieves sinus congestion and pressure
• helps clear nasal passages
• shrinks swollen membranes

Zicam Nasal Spray Warnings

Ask a doctor before use if you have:

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland

When using this product:

• do not use more than directed
• do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
• temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may result
• use of this container by more than one person may spread infection

Stop use and ask a doctor if symptoms persist

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Zicam Nasal Spray Directions of Use

To use pump:

• to open, hold the actuator to squeeze and turn cap
• hold with thumb at bottom of bottle and nozzle between fingers
• before using the first time, prime pump by depressing several times
• place tip of nozzle just past nasal opening (approximately 1/8″)
• pump 2 or 3 times in each nostril without tilting your head. Sniff deeply.
• wipe nozzle clean after use
• to close, turn cap until it ‘clicks’

Zicam Nasal Spray Dose

• Adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period.
• Children under 6 years of age: Ask a doctor

Zicam side effects

Zicam (Oxymetazoline) may cause side effects.

Common side effects

• Transient burning, stinging, increased nasal discharge
• Dryness inside the nose
• Sneezing
• Difficulty falling asleep or staying asleep
• Rebound congestion with prolonged use (4-5 days)
• Rebound congestion is associated with overuse and may take several weeks to reverse

Tell your doctor if any of these symptoms are severe or do not go away.

Uncommon side effects

• Hypertension
• Nausea
• Nervousness
• Dizziness
• Drowsiness
• Insomnia
• Headache
• CNS (central nervous system) effects are more common in children

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fast heartbeat
• slow heartbeat

Oxymetazoline nasal spray may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

Human Toxicity Reports

Intranasal use of oxymetazoline may occasionally cause systemic sympathomimetic effects such as hypertension, nervousness, nausea, dizziness, headache, insomnia, palpitation, or reflex bradycardia ¹.

A total of 307 patients with acute rhinitis entered a study to compare the difference between oxymetazoline with preservative and oxymetazoline without preservative. The treatment with oxymetazoline with preservative and oxymetazoline without preservative and xylometazoline with preservative was evaluated. This randomized, double-blind, multi-centered, tolerance study confirmed that the local sympathomimetics oxymetazoline and xylometazoline are well tolerated in the treatment of acute rhinitis. When evaluated according to the parameters “feeling of dryness in nasal mucosa” and “burning sensation”, a 0.05% spray, which contains the active agent oxymetazoline without preservatives, proved to be considerably superior to preparations containing the preservative benzalkonium chloride ⁵.

A case report of an abrupt withdrawal in a healthy man of oxymetazoline nasal spray precipitated a prolonged panic disorder that required hospitalization with extensive evaluations ⁶.

Excessive dosage and/or prolonged or too frequent intranasal use of oxymetazoline may irritate nasal mucosa and especially in children, cause adverse systemic effects. Excessive dosage or inadvertent ingestion in children may cause profound CNS (central nervous system) depression, possibly necessitating intensive supportive care ¹. CNS depression, shock-like hypotension, and coma have occurred following overdosage of naphazoline and tetrahydrozoline; the possibility that this may occur with oxymetazoline should be considered ¹.

In this case report, oxymetazoline nasal spray 0.025% was administered to a 2-year-old patient during general anesthesia for nasal endoscopy. Severe hypertension with reflex bradycardia progressed to sinus arrest and was successfully treated with atropine and cardiopulmonary resuscitation ⁷.

A patient prescribed oxymetazoline hydrochloride nasal drops presented with recurrent ventricular tachycardia of fascicular origin ⁸. Cardiac ultrasound showed a calcified lesion, presumably a fibroma arising from the interventricular septum. Fascicular tachycardia related to the lesion and provoked by the use of a sympathomimetic agent is postulated ⁸.

A case of chronic use of nasal oxymetazoline associated with thunderclap headache due to reversible segmental intracranial vasoconstriction is reported ⁹. The patient had been using a nasal spray that contains oxymetazoline, regularly for the previous 6 months ⁹. Although she was using the medication at recommended daily dosages (2–3 sprays twice daily), she was using it consistently. Two weeks before presentation she had noticed a pattern of headache starting 20 minutes after use of the nasal spray. The event had occurred immediately after its use. Thunderclap headache is a hyperacute, severe headache that is so named because of its sudden onset. It often heralds a serious intracranial vascular event such as subarachnoid hemorrhage, cerebral venous sinus thrombosis or pituitary apoplexy. However, it may also occur spontaneously or in the setting of cerebral vasoconstriction. Narcotic analgesics reduced the pain, but the nausea and vomiting responded to ondansetron only. The patient had no improvement in her headache with nimodipine, a calcium-channel antagonist that causes dilatation of arterial smooth muscle. Two weeks after discharge the headache had nearly resolved. A repeat angiogram at 6 weeks showed complete resolution of most areas of arterial narrowing ⁹. This case report illustrates that oxymetazoline can cause reversible segmental cerebral vasoconstriction, resulting in thunderclap headache.

A case report of 43-year-old woman who was evaluated for sequential bilateral vision loss following the use of oxymetazoline nasal spray. Thorough investigation of possible causes causing the bilateral anterior ischemic optic neuropathy was negative. The patient had several predisposing risk factors for ischemic optic neuropathy, including diabetes mellitus, hypertension, and crowded optic nerve heads. Before each acute optic neuropathy, the patient used two to three puffs of oxymetazoline nasal spray ¹⁰.

A case report of a young, otherwise healthy man presented with an acute retinal artery obstruction following excessive use of oxymethazolone hydrochloride 0.5% nasal spray ¹¹. Platelet coagulation studies indicated a platelet aggregation hypersensitivity to adenosine diphosphate and epinephrine. A predisposition for sympathomimetic drug-induced platelet fibrin embolus formation appears to be the cause of the retinal artery obstruction in this case ¹¹.

A case is presented in which a 73-yr-old man who was using Afrin (oxymetazoline hydrochloride) nasal spray several times daily, for the treatment of nasal congestion, developed bradycardia, hypotension and dizziness associated with oxymetazoline hydrochloride ¹².

1. McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2006., p. 2824
2. Baxi LV et al; J Obstet Gynecol 153 (Dec): 799 -800, 1985
3. Rayburn WF, et al; Obstet Gynecol 76 (2): 180-2, 1990
4. Anderson PO. Decongestants and milk production. J Hum Lact. 2000;16:294 https://www.ncbi.nlm.nih.gov/pubmed/11155604
5. Dorn M et al; HNO 51 (10): 794-9, 2003 https://www.ncbi.nlm.nih.gov/pubmed/14523532
6. Saadah HA; J Clin Psychiarty 48 (7): 293, 1987 https://www.ncbi.nlm.nih.gov/pubmed/3597333
7. Thrush DN; J Clin Anesth 7 (6): 5112-4; 1995 https://www.ncbi.nlm.nih.gov/pubmed/8534470
8. Khan A, Dewhurst N; Br J Clin Pract 51 (3): 192-3, 1997 https://www.ncbi.nlm.nih.gov/pubmed/9293069
9. Loewen AHS, Hudon ME, Hill MD. Thunderclap headache and reversible segmental cerebral vasoconstriction associated with use of oxymetazoline nasal spray. CMAJ : Canadian Medical Association Journal. 2004;171(6):593-594. doi:10.1503/cmaj.1040631. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC516194/
10. Fivhas GD, Newman NJ; Am J Ophthalmol 127 (1): 104-6, 1999 https://www.ncbi.nlm.nih.gov/pubmed/9933016
11. Magargal LE et al; Ann Ophthalmol 17 (8): 500-1,1985 https://www.ncbi.nlm.nih.gov/pubmed/2413795
12. Glazener F et al; N Engl J Med 309 (Sep 22): 731, 1983