What is Zyrtec

Zyrtec is an antihistamine medicine that relieves the symptoms of allergies by blocking the effects of the chemical histamine in your body. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions. Zyrtec’s active ingredient is a compound called Cetirizine (IUPAC name: 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid) which is a non-drowsy antihistamine ¹. Zyrtec (cetirizine) was the first marketed drug from the series of second-generation antihistamines showing both minimal side effects on the central nervous system and a reduced level of cardiotoxicity ¹. Zyrtec (cetirizine) is much less likely to make you feel sleepy than some other first generation or older antihistamines.

Zyrtec (cetirizine) is used to treat hay fever or allergy symptoms such as allergic conjunctivitis (red, itchy eye), eczema and hives. It’s also used for reactions to insect bites and stings and for some food allergies and the symptoms of common cold.

When you come into contact with something you’re allergic to, such as pollen, animal hair or fur, house dust or insect bites and stings, your body produces a chemical called histamine.

Usually histamine is a useful substance but in an allergic reaction it causes unpleasant symptoms including itchy, watery eyes, running or blocked nose, sneezing and skin rashes.

Zyrtec (cetirizine) blocks the effects of histamine and reduces these symptoms.

Key facts:

• It’s usual to take Zyrtec (cetirizine) once a day. Children sometimes take it twice a day.
• Zyrtec (cetirizine) is classed as a non-drowsy antihistamine, but some people still find it makes them feel quite sleepy.
• Common side effects include headache, dry mouth, feeling sick, dizziness, tummy pain and diarrhea.
• It’s best not to drink alcohol while you’re taking Zyrtec (cetirizine) as it can make you feel sleepy.
• Cetirizine is sold under the trade names Benadryl Allergy, Piriteze, Zirtec, Zyrtec, and Reactine.

Zyrtec (cetirizine) is available on prescription. You can also buy it from pharmacies and supermarkets.

Zyrtec (cetirizine) comes as tablets, capsules and as a liquid that you swallow.

Despite Zyrtec (cetirizine) is being marketed as a non-drowsy antihistamine, it may still impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of Zyrtec.

Tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by Zyrtec. Call your doctor if your symptoms do not improve, if they get worse, or if you also have a fever.

How long does it take for zyrtec to work?

Cetirizine starts to work within 30 – 60 minutes after being taken. You should start to feel better within an hour.

How long should I take Zyrtec (cetirizine) for?

It depends on why you’re taking Zyrtec (cetirizine).

You may only need to take it for a short time or as a one-off dose. For example, if you have a reaction to an insect bite, you may only need to take Zyrtec (cetirizine) for a day or 2.

You may need to take Zyrtec (cetirizine) for longer if you’re taking it to prevent symptoms – for example, to stop hay fever when the pollen count is high.

Talk to your doctor or pharmacist if you’re unsure how long you need to take Zyrtec (cetirizine) for.

Is it safe to take Zyrtec (cetirizine) for a long time?

Zyrtec (cetirizine) is unlikely to do you any harm if you take it for a long time. However, it’s best to take Zyrtec (cetirizine) only for as long as you need to.

Can I drink alcohol with Zyrtec?

It’s best not to drink alcohol while you’re taking Zyrtec (cetirizine) as it can make you feel sleepy.

Is there any food or drink I need to avoid?

You can eat and drink normally while taking Zyrtec (cetirizine).

Can I drive or ride a bike with Zyrtec?

Zyrtec (cetirizine) is classed as a non-drowsy antihistamine but it’s still possible to feel sleepy after taking it.

If this happens to you, don’t drive a car or ride a bike until you feel better.

What’s the difference between Zyrtec (cetirizine) and other antihistamines?

Zyrtec (cetirizine) is known as a non-drowsy antihistamine. That’s because it’s less likely to make you feel sleepy than other, so-called sedating antihistamines such as Benadryl (diphenhydramine).

Most people prefer to take a non-drowsy antihistamine instead of a sedating one. An exception is when you want the medicine to make you sleepy, for example if you have itchy skin that’s keeping you awake.

What’s the difference between Zyrtec (cetirizine) and other non-drowsy antihistamines?

Other non-drowsy antihistamines like Loratadine, Desloratadine, Fexofenadine, Levocetirizine seem to work just as well as Zyrtec (cetirizine).

However, Zyrtec (cetirizine) seems to be more likely to make you feel sleepy than loratadine, desloratadine or fexofenadine.

Can I take Zyrtec with painkillers?

Yes, you can take Zyrtec (cetirizine) together with Tylenol (acetaminophen) or Motrin (ibuprofen).

Can I take more than one antihistamine together?

Sometimes doctors recommend that people with severe itchy skin rash take 2 different antihistamines together for a few days.

As well as taking a non-drowsy antihistamine during the day (such as Zyrtec or loratadine), your doctor may advise that you take a sedating antihistamine at night time if the itch is making it difficult to sleep.

Do not take 2 antihistamines together unless recommended by your doctor.

Can I take Zyrtec with other hay fever treatments?

Yes, it’s fine to take Zyrtec (cetirizine) together with other hay fever treatments, for example steroid nasal sprays (such as Beconase, Rhinacort Aqua and Flixonase Nasules) or eye drops.

Will Zyrtec affect my fertility?

There’s no evidence that Zyrtec (cetirizine) affects male or female fertility.

Will Zyrtec affect my contraception?

Zyrtec (cetirizine) does not affect any type of contraception including the contraceptive pill and the morning after pill.

Can lifestyle changes relieve hay fever?

It will help if you don’t spend too much time outside if the pollen count is high. Also:

Tips for when you’re outside:

• Don’t cut grass or walk on grass.
• Wear wraparound sunglasses to stop pollen getting into your eyes.
• Put Vaseline around your nostrils to help trap pollen.
• Shower and change your clothes after you’ve been outside to wash off pollen.

Tips for when you’re inside:

• Keep windows and doors shut as much as possible.
• Vacuum regularly and dust with a damp cloth.
• Don’t keep fresh flowers in the house.
• Don’t smoke or be around smoke as it makes hay fever symptoms worse.

Who can and can’t take Zyrtec

Zyrtec (cetirizine) tablets and liquid that you buy from pharmacies and supermarkets can be taken by adults and children aged 6 and older.

Children over the age of 2 can also take liquid Zyrtec (cetirizine) for hay fever and skin allergies.

Zyrtec (cetirizine) can also be taken under medical supervision by children aged 1 year and older.

Zyrtec (cetirizine) isn’t suitable for some people. Tell your doctor or pharmacist if you:

• have had an allergic reaction to Zyrtec (cetirizine) or any other medicines in the past
• have an allergy to peanuts or soya
• have an allergy to the food additives, E218 or E216
• have an intolerance to, or cannot absorb, some sugars such as lactose or sorbitol
• have liver or kidney failure
• have epilepsy or another health problem that puts you at risk of fits
• have an illness that means you’re more likely to retain urine
• are booked to have an allergy test – taking Zyrtec (cetirizine) may affect the results, so you might need to stop taking it a few days before the test

Pregnancy and breastfeeding

You can take Zyrtec (cetirizine) while you’re pregnant. However a similar antihistamine called loratadine is normally used first because there’s more information to say that it’s safe.

• Zyrtec (cetirizine) isn’t thought to be harmful during pregnancy, but as very few pregnant women have been studied, it is not possible to be certain.

Talk to your doctor about the benefits and possible harms of taking Zyrtec (cetirizine). It will also depend on how many weeks pregnant you are and the reason you need to take Zyrtec (cetirizine).

To assess the safety of cetirizine during pregnancy, a prospective observational cohort study with data from 1992 until 2006 was conducted ². Pregnancy outcome was compared between a cohort of pregnant women exposed to cetirizine during the first trimester (n=196) and a control group not exposed to potential teratogens (n=1686). Major birth defects were not more common in the study group than in the control group ². The investigators also compared the crude rate of spontaneous abortions of preterm deliveries and the birth weight of term newborns. This prospective observational study on cetirizine in pregnancy suggests that the use of cetirizine is relatively safe during the first trimester ².

Zyrtec (cetirizine) and breastfeeding

It’s usually safe to take cetrizine if you’re breastfeeding as only small amounts get into breast milk.

However, speak to your doctor before taking Zyrtec (cetirizine) if your baby was premature, had a low birth weight or has other health problems.

What is zyrtec used for

Zyrtec (cetirizine) is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Zyrtec (cetirizine) is also used to treat itching and redness caused by hives. However, Zyrtec (cetirizine) does not prevent hives or other allergic skin reactions.

Zyrtec (cetirizine) comes as a tablet, a chewable tablet, an extended release tablet, and a syrup (liquid) to take by mouth. It is usually taken once a day with or without food. Take Zyrtec (cetirizine) at around the same time every day. Follow the directions on the package label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Zyrtec (cetirizine) exactly as directed. Do not take more or less of it or take it more often than directed on the package label or as recommended by your doctor.

• Do NOT use Zyrtec (cetirizine) to treat hives that are bruised or blistered, that are an unusual color, or that do not itch. Call your doctor if you have these types of hives.

Stop taking Zyrtec (cetirizine) and see your doctor if your hives do not improve during the first 3 days of your treatment or if your hives last longer than 6 weeks. If you do not know the cause of your hives, see your doctor.

If you are taking Zyrtec (cetirizine) to treat hives, and you develop any of the following symptoms, get emergency medical help right away:

• difficulty swallowing, speaking, or breathing;
• swelling in and around the mouth or swelling of the tongue;
• wheezing; drooling; dizziness; or loss of consciousness.

These may be symptoms of a life-threatening allergic reaction called anaphylaxis. If your doctor suspects that you may experience anaphylaxis with your hives, he may prescribe an epinephrine injector (EpiPen). Do not use Zyrtec (cetirizine) in place of the epinephrine injector.

Zyrtec (cetirizine) is also available in combination with pseudoephedrine (Sudafed, others). If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Zyrtec dosage

Before taking Zyrtec

• tell your doctor and pharmacist if you are allergic to Zyrtec (cetirizine), hydroxyzine (Vistaril), 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: antidepressants, medications for anxiety, medications for mental illness, medications for seizures, other medications for cold and allergy, sedatives, sleeping pills, tranquilizers, and theophylline (Theo-24, Theolair). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Zyrtec (cetirizine), call your doctor.
• you should know that Zyrtec (cetirizine) may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. Avoid drinking alcoholic beverages while taking this medication.

Cautions with other medicines

Some medicines and Zyrtec (cetirizine) interfere with each other and increase the chances of you having side effects. Check with your pharmacist or doctor if you’re taking:

• midodrine, a medicine used to treat low blood pressure
• ritonavir, a medicine used to treat HIV infection
• any medicine that makes you drowsy, gives you a dry mouth, or makes it difficult for you to pee. Taking Zyrtec (cetirizine) might make these side effects worse.

Mixing Zyrtec (cetirizine) with herbal remedies and supplements

There might be a problem taking some herbal remedies and supplements alongside Zyrtec (cetirizine) – especially ones that cause sleepiness, a dry mouth or make it difficult to urinate.

Ask your pharmacist for advice.

How and when to take Zyrtec

If you or your child have been prescribed Zyrtec (cetirizine), follow your doctor’s instructions about how and when to take it. If you’ve bought Zyrtec (cetirizine) from a pharmacy or shop, follow the instructions that come with the packet.

How much should I take?

Zyrtec (cetirizine) comes as tablets and capsules (10mg) and as a liquid medicine (labeled either 5mg/ml or 1mg/1ml).

The usual dose in adults is 10mg once daily. A 5 mg product may be appropriate for less severe symptoms.

Doses are usually lower for people with liver or kidney problems.

For children, your doctor will use your child’s weight or age to work out the right dose. If you’ve bought Zyrtec (cetirizine) for a child, follow the instructions on the packet.

Depending on their age, children may take Zyrtec (cetirizine) twice a day. In this case, try to space the doses 10 to 12 hours apart.

Zyrtec dosing information

Zyrtec Adult Dosage

Usual Adult Dose for Allergic Rhinitis

• 5 to 10 mg orally or chewed once a day

Usual Adult Dose for Urticaria

• 5 to 10 mg orally or chewed once a day

Adults 65 years and over

• 5 mg once a day; do not take more than 5 mg in 24 hours.

Dose Adjustment for Renal and Hepatic Impairment

In patients 12 years of age and older with decreased renal function (creatinine clearance 11–31 mL/min), patients on hemodialysis (creatinine clearance less than 7 mL/min), and in hepatically impaired patients, a dose of 5 mg once daily is recommended. Similarly, pediatric patients aged 6 to 11 years with impaired renal or hepatic function should use the lower recommended dose. Because of the difficulty in reliably administering doses of less than 2.5 mg (½ teaspoon) of ZYRTEC syrup and in the absence of pharmacokinetic and safety information for cetirizine in children below the age of 6 years with impaired renal or hepatic function, its use in this impaired patient population is not recommended.

How to take Zyrtec (cetirizine)

You can take Zyrtec (cetirizine) with or without food.

Always take Zyrtec (cetirizine) tablets or capsules with a drink of water, milk or juice. Swallow them whole. Do not chew them.

Zyrtec (cetirizine) liquid may be easier for children to take than tablets or capsules. The liquid medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don’t have a syringe or spoon, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.

When to take Zyrtec (cetirizine)

You may only need to take Zyrtec (cetirizine) on a day you have symptoms, such as if you’ve been exposed to a trigger like animal hair. Or you may need to take it regularly to prevent symptoms, such as to stop hay fever during spring and summer.

What if I forget to take Zyrtec?

Take your forgotten dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you forget to give a dose to a child who is taking Zyrtec (cetirizine) twice a day, you can give the dose if it’s within 4 hours of when they should have had it. If you remember more than 4 hours after, do not give the missed dose. Instead, wait until the next dose and carry on 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 Zyrtec?

Zyrtec (cetirizine) is generally very safe. Taking too much is unlikely to harm you or your child.

If you take an extra dose by mistake, you might get some of the common side effects. If this happens or you’re concerned, contact your doctor.

Can I take Zyrtec (cetirizine) at higher doses than on the packet?

Your doctor might suggest you or your child take a higher dose of Zyrtec (cetirizine) (up to 4 times the usual dose) for severe itchy skin rash or angioedema (swelling underneath the skin).

Taking high doses of Zyrtec (cetirizine) isn’t suitable for everyone though. Speak to your doctor if you think Zyrtec (cetirizine) isn’t working for you.

Zyrtec Children Dosage

Zyrtec (cetirizine) is usually given once or twice each day.

• Once a day: it can be given in the morning or the evening.
• Twice a day: give once in the morning and once in the evening. Ideally, these times are 10–12 hours apart, for example some time between 7 and 8 am, and between 7 and 8 pm.

Give the medicine at about the same time(s) each day so that this becomes part of your child’s daily routine, which will help you to remember.

Usual Pediatric Dose for Allergic Rhinitis:

• 6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.
• 2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.
• 6 years or older: 5 to 10 mg orally or chewed once a day.

Usual Pediatric Dose for Urticaria:

• 6 months to 2 years: 2.5 mg orally once a day, 12 months and older may be increased to 2.5 mg orally twice a day.
• 2 to 5 years: 2.5 mg orally once a day, may be increased to 5 mg/day in 1 to 2 divided doses.
• 6 years or older: 5 to 10 mg orally or chewed once a day.

What if my child is sick (vomits)?

• If your child is sick less than 30 minutes after having a dose of Zyrtec (cetirizine), give them the same dose again.
• If your child is sick more than 30 minutes after having a dose of Zyrtec (cetirizine), you do not need to give them another dose. Wait until the next normal dose.

If your child is sick again, seek advice from your doctor, pharmacist or hospital. They will decide what to do based on your child’s condition and the specific medicine involved.

What if I forget to give it?

If you normally give it once a day in the morning

• Give the missed dose when you remember during the day.

If you normally give it once a day in the evening

• If you remember before bedtime, give the missed dose. If you remember after this, you do not need to wake your child up to give them the missed dose. You can give the missed dose in the morning.

If you normally give it twice a day

• If you remember up to 4 hours after you should have given a dose, give your child the missed dose. For example, if you usually give a dose at about 7 am, you can give the missed dose at any time up to 11 am. If you remember after that time, do not give the missed dose. Wait until the next normal dose.

What if I give too much?

Zyrtec (cetirizine) is generally a safe drug, and you are unlikely to do harm if you give your child an extra dose of Zyrtec (cetirizine) by mistake. If you are worried that you may have given your child too much, contact your doctor or local pharmacist. Have the medicine packet with you if you telephone for advice.

Are there any possible side-effects?

You use medicines to make your child better, but sometimes they have other effects that you don’t want (side-effects).

• If your child gets palpitations (they may feel a fluttery feeling in chest or say that their heart is racing), contact your doctor straight away or take your child to hospital.

Other side-effects you need to know about:

• Your child may feel sleepy, drowsy or sluggish after taking cetirizine. This can last for a few hours, so it may be better to give cetirizine in the evening rather than the morning.
• Your child may get a dry mouth. Eating citrus fruits (e.g. oranges) or taking sips of water may help.
• Your child’s eyesight may be blurred (fuzzy).
• Your child may have constipation (difficulty doing a poo, or doing a poo less often than usual). Encourage them to drink plenty of fluid and to eat foods that contain fiber (e.g. wholemeal foods, fruit and vegetables). If this is still a problem after 2 weeks, contact your doctor.
• Your child may find that they urinate (do a wee) less often, or have difficulty doing a wee.
• Your child may feel light headed and faint (dizziness). Encourage them not to stand up too quickly, and to sit or lie down if they feel dizzy.
• They may get headaches when they first start taking cetirizine.

There may, sometimes, be other side-effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor.

Can other medicines be given at the same time as Zyrtec (cetirizine)?

• You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
• Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal or complementary medicines.

Is there anything else I need to know about Zyrtec (cetirizine)?

• If your child continues to get symptoms of hay fever, contact your doctor. They may consider other treatments.
• Symptoms of eczema and asthma may get worse during the hay fever season. If this happens, contact your doctor.

Where should I keep this medicine?

• Keep the medicine in a cupbord, away from heat and direct sunlight. It does not need to be kept in the fridge.
• Make sure that children cannot see or reach the medicine.
• Keep the medicine in the container it came in.

Zyrtec side effects

Like all medicines, Zyrtec (cetirizine) can cause side effects although not everyone gets them.

The most commonly reported side effects include somnolence, dizziness, and headache.

Common side effects

Common side effects of Zyrtec (cetirizine) 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:

• feeling sleepy and tired
• drowsiness
• excessive tiredness
• headache
• dry mouth
• feeling sick or dizzy
• stomach pain
• diarrhea
• vomiting
• sore throat
• cold-like symptoms of the nose
• itch or rash
• tingling in the hands and feet
• feeling agitated

Children are more likely to get diarrhea or cold-like symptoms of the nose than adults.

Nervous system

• Very common (10% or more): Somnolence (up to 14.3%), headache (up to 14%)
• Common (1% to 10%): Dizziness
• Frequency not reported: Altered sense of taste, paresthesia, hypertonia, tremor, abnormal coordination/incoordination, ataxia, hyperesthesia, hyperkinesia, hypoesthesia, migraine, paralysis, twitching, parosmia, taste loss/perversion
• Postmarketing reports: Convulsions, dysgeusia, dyskinesia, dystonia, syncope, amnesia, vertigo, memory impairment

Gastrointestinal

• Common (1% to 10%): Dry mouth, nausea, diarrhea, vomiting, abdominal pain
• Uncommon (0.1% to 1%): Dyspepsia
• Frequency not reported: Tongue disorder, constipation, flatulence, increased salivation, aggravated tooth caries, eructation, gastritis, hemorrhoids, melena, rectal hemorrhage, stomatitis/ulcerative stomatitis, tongue discoloration/edema, enlarged abdomen

Respiratory

• Common (1% to 10%): Pharyngitis, rhinitis, coughing, epistaxis
• Frequency not reported: Dyspnea, respiratory disorder, bronchospasm, upper respiratory tract infection, dysphonia, bronchitis, hyperventilation, increased sputum, pneumonia, sinusitis, nasal polyp

Other

• Common (1% to 10%): Fatigue
• Frequency not reported: Earache, tinnitus, fever, pain, rigor, thirst, deafness, ototoxicity, accidental injury, face edema, leg edema, malaise
• Postmarketing reports: Asthenia, stillbirth

Psychiatric

• Common (1% to 10%): Insomnia
• Frequency not reported: Nervousness, impaired concentration, confusion, decreased libido, abnormal thinking, anxiety, depersonalization, emotional lability, euphoria, paroniria, sleep disorder
• Postmarketing reports: Agitation, aggression/aggressive reaction, depression, hallucination, tic, suicidal ideation/suicide

Musculoskeletal

• Very rare (less than 0.01%): Myelitis
• Frequency not reported: Back pain, myalgia, arthralgia, bone disorder/fracture, leg cramps, arthritis, arthrosis, muscle weakness

Dermatologic

• Frequency not reported: Pruritus/intense itching, increased sweating, acne, alopecia, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, maculopapular rash, photosensitivity/photosensitivity toxic reaction, purpura, seborrhea, skin disorder/nodule
• Postmarketing reports: Rash, urticaria, angioneurotic edema, fixed drug eruption, acute generalized exanthematous pustulosis

Ocular

• Frequency not reported: Eye abnormality, periorbital edema, abnormal vision, eye pain, conjunctivitis, ptosis, visual field defects, blindness, glaucoma, ocular hemorrhage, xerophthalmia, periorbital edema/eye swelling
• Postmarketing reports: Accommodation disorder/loss of accommodation, blurred vision, oculogyration, orofacial dyskinesia

Genitourinary

• Frequency not reported: Polyuria, urinary retention, urinary tract infection, dysmenorrhea, hematuria, micturition frequency, urinary incontinence, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis
• Postmarketing reports: Dysuria, enuresis

Cardiovascular

• Frequency not reported: Flushing, palpitations, tachycardia, edema/general edema, chest pain, cardiac failure, hypertension, hot flashes, peripheral edema, pallor
• Postmarketing reports: Severe hypotension

Metabolic

• Frequency not reported: Increased appetite, anorexia, increased weight, dehydration, diabetes mellitus

Hepatic

• Frequency not reported: Reversible transaminase elevations
• Postmarketing reports: Abnormal hepatic function (increased transaminases, alkaline phosphatase, GGT, bilirubin), cholestasis, hepatitis

Hypersensitivity

• Frequency not reported: Allergic reactions/delayed allergic reactions
• Postmarketing reports: Hypersensitivity, anaphylactic shock

Hematologic

• Frequency not reported: Lymphadenopathy
• Postmarketing reports: Thrombocytopenia, hemolytic anemia

Renal

• Frequency not reported: Cystitis
• Postmarketing reports: Glomerulonephritis

Serious side effects

It’s rare to have a serious side effect with Zyrtec (cetirizine).

Tell your doctor straight away if you have:

• bruising or bleeding that’s more than normal
• difficulty breathing or swallowing

Zyrtec (cetirizine) may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction to Zyrtec (cetirizine). 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 Zyrtec (cetirizine). For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor.
• feeling sick – stick to simple meals and don’t eat rich or spicy food
• headache – take an everyday painkiller like paracetamol or ibuprofen
• dry mouth – chew sugar-free gum or suck sugar-free sweets
• diarrhea – drink plenty of water in small, frequent sips. It may also help to take oral rehydration solutions like pedialyte. You can buy these from a pharmacy or supermarket to prevent dehydration. Don’t take any other medicines to treat diarrhea without speaking to a pharmacist or a doctor.

Human Toxicity Reports

In a controlled study of 1 week’s duration in patients 6-11 months of age, those receiving cetirizine exhibited greater irritability/fussiness than those receiving placebo. In a controlled study in patients 12 months of age and older, insomnia occurred more frequently with cetirizine than with placebo (9 vs 5.3%, respectively). In those who received 5 mg or more daily, fatigue occurred in 3.6 or 1.3% and malaise in 3.5 or 1.8% of those receiving cetirizine or placebo, respectively ³.

Fatigue or dizziness occurred in 5.9 or 2%, respectively, of patients 12 years of age and older receiving cetirizine, whereas these effects occurred in 2.6 or 1.2%, respectively, of patients receiving placebo ⁴. Headache was reported in more than 2% of patients 12 years of age and older receiving the drug; however, headache occurred more frequently in patients receiving placebo. In clinical trials in patients 6-11 years of age, headache occurred in 11, 14, or 12.3% of patients receiving 5-mg doses, 10-mg doses, or placebo, respectively. Abnormal coordination, ataxia, confusion, abnormal thinking, agitation, amnesia, anxiety, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, sleep disorders, nervousness, paroniria, dysphonia, asthenia, malaise, pain, hyperesthesia, hypoesthesia, hyperkinesia, hypertonia, migraine headache, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, and vertigo have been reported in less than 2% of patients 12 years of age and older and children 6-11 years of age receiving cetirizine hydrochloride; however, a causal relationship to the drug has not been established. Aggressive reaction, seizures, hallucinations, suicidal ideation, and suicide have been reported rarely during postmarketing surveillance ⁴.

The most frequent adverse effect in patients 12 years of age and older reported during cetirizine therapy is somnolence, occurring in 11, 14, or 6% of patients receiving 5-mg doses, 10-mg doses, or placebo, respectively ⁴. Overall, somnolence has been reported in 13.7 or 6.3% of patients receiving cetirizine or placebo, respectively. In addition, in clinical trials in patients 6-11 years of age, somnolence occurred in 1.9, 4.2, or 1.3% of patients receiving 5-mg doses, 10-mg doses, or placebo, respectively. Discontinuance of therapy because of somnolence has been reported in 1 or 0.6% of patients receiving cetirizine or placebo, respectively.1 3 In patients 6-24 months of age, somnolence occurred with essentially the same frequency in those who received cetirizine versus placebo.

Adverse effects reported in 1% or more of patients 12 years of age and older with seasonal allergic rhinitis who received extended-release tablets of cetirizine hydrochloride in fixed combination with pseudoephedrine hydrochloride (Zyrtec-D) included insomnia, dry mouth, fatigue, somnolence, pharyngitis, epistaxis, accidental injury, dizziness, and sinusitis ⁴.

A case of recurrent acute hepatitis related to the use of cetirizine has been described in a 26-year-old man who was hospitalized with a week-long history of weakness, nausea, anorexia, and hyperchromic urine, which had developed after 6 days of therapy with oral cetirizine 10 mg/day for allergic rhinitis ⁵. Admission laboratory testing revealed evidence of acute hepatitis and seropositivity for liver-kidney microsome antibodies. Liver biopsy findings of diffuse portal tract and lobular inflammation with a prominent eosinophilic infiltrate were consistent with drug-related hepatitis. The patient was discharged after one week of treatment with tocopherol and glutathione. Three months after discharge, transaminase levels were normal. At 6 months, seropositivity for liver-kidney microsome antibodies was still present, but considerably less intense. The patient had suffered 2 previous episodes of “acute hepatitis of unknown origin,” and both had occurred after cetirizine use ⁵. The study authors indicated cetirizine as the probable cause of acute hepatitis, and the positivity for liver-kidney microsome antibodies is suggestive of an autoimmune mechanism for liver damage. This is the fourth reported case of acute hepatitis associated with cetirizine and the second in which liver-kidney microsome antibodies have been documented. Although cetirizine is considered to have low potential for severe hepatic toxicity, the possibility that it can provoke autoimmune-mediated hepatotoxicity should be considered ⁵.

In U.S. clinical trials, transient reversible hepatic transaminase elevations were observed in <2% of patients during cetirizine therapy ⁶. A case of cetirizine-induced cholestasis in a 28-year-old man with no previous hepatobiliary disease after a 2-year period of taking cetirizine on a daily basis is reported. The treatment of this patient included the use of ursodeoxycholic acid, as well as hydroxyzine, for symptomatic relief of pruritus. In light of the patient’s clinical and biochemical improvement while using hydroxyzine, it appears that the hepatic metabolism of hydroxyzine to metabolites, including cetirizine, is involved in the pathogenesis of this particular case of drug-induced hepatotoxicity. Cetirizine should be considered as a potential cause of drug-induced cholestasis ⁶.

The case of a 29-yr-old woman with pruritus sine materiae who was receiving treatment with oral tablets of 20 mg of cetirizine hydrochloride daily, after which she developed generalized chronic urticaria associated with cetirizine administration is presented ⁷. The patient was admitted for diagnostic purposes, and cetirizine was stopped on admission. Surprisingly, the patient’s urticarial lesions resolved completely within 4 days. Subsequently, the patient showed a pseudoallergic response to a cellular antigen stimulation test performed with cetirizine. The patient was rechallenged with cetirizine 7 wk after discharge. The patient developed a generalized wheal reaction 15 min after an oral dose of 5 mg of cetirizine ⁷.

Dystonia is a movement disorder that causes involuntary contractions of the muscles. Dystonia can affect just one muscle, a group of muscles, or all of the muscles. The most common cause of acquired dystonia in childhood is drugs. Cetirizine is widely used for allergic disorders in childhood. It is without central nervous system side effects at recommended dosages. A case of cetirizine-induced acute acquired dystonia whose symptoms completely resolved after the discontinuation of the drug is reported ⁸.

Cetirizine can cause oculogyric crisis, especially in the pediatric age group according to a retrospective, observational case series and case reports that were collected from the National Registry of Drug-Induced Ocular Side Effects (Casey Eye Institute, Portland, Oregon) ⁹.

Zyrtec 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.

Symptoms of Zyrtec overdose may include:

• restlessness
• irritability
• drowsiness

A case of a 18-year-old female with the history of anorexia for 2 years, who was admitted to a Clinic of Toxicology because of suicidal attempt with use of cetirizine is presented ¹⁰. The laboratory results revealed metabolic acidosis with the pH 7.13; pO2 88 mm Hg; pCO2 36 mm Hg; HCO3 12.0 mmol/L; BE (-)17 mmol/L; SO2 100% and hypokalemia (K+ 3.1 mmol/L). On physical examination blood pressure was 70/40 mm Hg, heart rate was 36-40 beats/min. Convulsions were observed. After about two hours of intensive treatment there was a cardiac arrest in the form of ventricular fibrillation. The resuscitation procedures which lasted for over 2.5 hours were ineffective ¹⁰.. The high dose (270 mg) of cetirizine as well as anorexia and hypokalemia could have been the cause of the unique character of the symptoms in this case. Further investigations should be carried out to confirm the safety of cetirizine in the conditions of massive intoxication and with coexistence of other risk factors ¹⁰.

In one adult patient who took 150 mg of Zyrtec, the patient was somnolent but did not display any other clinical signs or abnormal blood chemistry or hematology results. In an 18 month old pediatric patient who took an overdose of Zyrtec (approximately 180 mg), restlessness and irritability were observed initially; this was followed by drowsiness ¹¹.

Few reports exist on the result of cetirizine overdose in children ¹². A case report of a 12 fold overdose of cetirizine in a four-year-old-boy (weight 20 kg) who accidentally ingested 60 mg. Vomiting was induced 1 1/2 hour after ingestion in the out-patient clinic at the local hospital because of severe drowsiness. Due to continued lethargy he was transferred to the referral pediatric department for further observation. He was fully recovered after five to six hours without any treatment ¹². Electrocardiographic monitoring was normal. Five incidents of cetirizine overdose in children have been reported previously. Drowsiness and sedation were observed, but no other side effects ¹². The risk of cardiac events related to an overdose of cetirizine is extremely small. A certain degree of sedation is to be expected.

A cardiac condition called Torsades de pointes has been associated hypokalemia. A case of a dialysed patient with chronic renal failure who had symptomatic episodes of torsades de pointes in the context of hypokalemia and cetirizine overdose has been described ¹³.

1. Handing KB, Shabalin IG, Szlachta K, Majorek KA, Minor W. Crystal structure of equine serum albumin in complex with cetirizine reveals a novel drug-binding site. Molecular immunology. 2016;71:143-151. doi:10.1016/j.molimm.2016.02.003. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800003/
2. Weber-Schoendorfer C, Schaefer C; Reprod Toxicol 26 (1): 19-23 (2008). https://www.sciencedirect.com/science/article/pii/S0890623808001238
3. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 27-8
4. American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 27
5. Pompili M et al; Ann Pharmacother 38 (11): 1844-7 (2004). Available from, as of July 24, 2009 https://www.ncbi.nlm.nih.gov/pubmed/15383643
6. Fong DG et al; J Clin Gastroenterol 31 (3): 250-3 (2000). Available from, as of July 6, 2009 https://www.ncbi.nlm.nih.gov/pubmed/11034010
7. Karamfilov T et al; Br J Dermatol 140 (5): 979-80; 1999 https://onlinelibrary.wiley.com/doi/full/10.1046/j.1365-2133.1999.02849.x
8. Esen I et al; Pediatr Emerg Care 24 (9): 627-8 (2008). Available from, as of July 10, 2009 https://www.ncbi.nlm.nih.gov/pubmed/18797375
9. Fraunfelder FW, Fraunfelder FT; Am J Ophthalmol 137 (2): 355-7;2004 https://www.ncbi.nlm.nih.gov/pubmed/14962433
10. Chodorowski Z et al; Przegl Lek 61 (4): 433-4 (2004). Available from, as of July 6, 2009 https://www.ncbi.nlm.nih.gov/pubmed/15521622
11. US Natl Inst Health; DailyMed. Current Medication Information for Zyrtec – cetirizine hydrochloride https://dailymed.nlm.nih.gov/dailymed/index.cfm
12. Hansen JJ et al; Ugeskr Laeger 160 (41): 5946-7 (1998). Available from, as of July 24, 2009 https://www.ncbi.nlm.nih.gov/pubmed/9786037
13. Renard S et al; Arch Mal Coeur Vaiss 98 (2): 157-61 (2005). Available from, as of July 24, 2009 https://www.ncbi.nlm.nih.gov/pubmed/15787309

What is tylenol

Tylenol is a pain reliever and a fever reducer medicine that contains an active ingredient called acetaminophen (paracetamol). Tylenol (acetaminophen) is a commonly used medicine to relieve mild or moderate pain, such as muscle aches, arthritis, backaches, menstrual periods, toothaches, colds, sore throats or sprains, reactions to vaccinations (shots) and reduce a high temperature (fever) caused by illnesses such as colds and flu.

Tylenol (acetaminophen) is often recommended as one of the first treatments for pain, as it’s safe for most people to take and side effects are rare. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products.

Tylenol (acetaminophen) has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Tylenol (acetaminophen) is a widely used nonprescription analgesic and antipyretic medication for mild-to-moderate pain and fever. Harmless at low doses, acetaminophen has direct hepatotoxic potential when taken as an overdose and can cause acute liver injury and death from acute liver failure. Even in therapeutic doses, acetaminophen can cause transient serum aminotransferase elevations (liver enzymes).

Tylenol (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). Tylenol (acetaminophen) works by changing the way the body senses pain and by cooling the body.

You can take tylenol for:

• mild to moderate pain, for example backache, headache, migraine, muscle strains, period pain, toothache and aches and pains due to colds and flu
• fever (high temperature)
• osteoarthritis and other painful, non-inflammatory conditions.

Is it okay to drink alcohol when I’m taking Tylenol (acetaminophen)?

Drinking a small amount of alcohol is unlikely to be harmful if you are taking tylenol (acetaminophen).

Tylenol pregnancy

Tylenol is considered the first choice of painkiller if you are pregnant since it has been taken by large numbers of pregnant women without any adverse effect on the mother or baby.

However, if you take tylenol when pregnant, make sure you take it for the shortest possible time.

Can I take tylenol if I’m breastfeeding?

Tylenol is the first choice of painkiller if you are breastfeeding.

It appears in breast milk in very small amounts which are unlikely to harm your baby.

If you take tylenol when breastfeeding, make sure you take it for the shortest possible time.

How does tylenol work?

Tylenol (acetaminophen) is a p-aminophenol derivative, an odorless compound with a slightly bitter taste with analgesic and antipyretic activities that seems to work by blocking chemical messengers in the brain that tell you that you have pain. Although the exact mechanism through which acetaminophen exert its effects has yet to be fully determined, acetaminophen may inhibit the nitric oxide (NO) pathway mediated by a variety of neurotransmitter receptors including N-methyl-D-aspartate (NMDA) and substance P, resulting in elevation of the pain threshold. The antipyretic activity may result from inhibition of prostaglandin synthesis and release in the central nervous system (CNS) and prostaglandin-mediated effects on the heat-regulating body temperature center in the anterior hypothalamus.

Tylenol (acetaminophen) is a widely used analgesic drug. It interacts with various enzyme families including cytochrome P450 (CYP), cyclooxygenase (COX), and nitric oxide synthase (NOS), and this interplay may produce reactive oxygen species (ROS) ¹. The effects of paracetamol (acetaminophen) on prostacyclin, thromboxane, nitric oxide (NO), and oxidative stress in four male subjects who received a single 3 g oral dose of paracetamol was investigated. Thromboxane and prostacyclin synthesis was assessed by measuring their major urinary metabolites 2,3-dinor-thromboxane B2 and 2,3-dinor-6-ketoprostaglandin F1 a, respectively. Endothelial NO synthesis was assessed by measuring nitrite in plasma. Urinary 15(S)-8-iso-prostaglanding F2 a was measured to assess oxidative stress. Plasma oleic acid oxide (cis-EpOA) was measured as a marker of cytochrome P450 activity. Upon paracetamol administration, prostacyclin synthesis was strongly inhibited, while NO synthesis increased and thromboxane synthesis remained almost unchanged. Paracetamol may shift the COX-dependent vasodilatation/vasoconstriction balance at the cost of vasodilatation. This effect may be antagonized by increasing endothelial NO synthesis. High-dosed paracetamol did not increase oxidative stress. At pharmacologically relevant concentrations, paracetamol did not affect NO synthesis/bioavailability by recombinant human endothelial NOS or inducible NOS in rat hepatocytes. It was concluded that paracetamol (acetaminophen) does not increase oxidative stress in humans ¹.

Is tylenol ibuprofen?

No. Ibuprofen belongs to one of a group of painkillers called non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is better for reducing inflammation (redness and swelling), including teething and toothache.

Whereas Tylenol (acetaminophen) is usually best for most types of pain, including headache and stomach ache.

Paracetamol and ibuprofen are similar strengths, but they work in different ways. So Tylenol (acetaminophen) is better for some types of pain than ibuprofen.

Do not give ibuprofen and paracetamol together, though. Instead, if you’ve given Tylenol (acetaminophen) to your child and they’re still feverish or in pain when the next dose is due, you could try ibuprofen instead.

Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both ibuprofen and paracetamol and they haven’t helped.

Who can take tylenol

Most people can take tylenol safely, including:

• pregnant women
• breastfeeding women
• children over 2 months of age – lower doses are recommended for young children

If you’re not sure whether you can take tylenol, check the leaflet that comes with it or ask your pharmacist or doctor for advice.

Always get advice before taking tylenol if you:

• have liver or kidney problems
• have problems with alcohol, such as long-term alcohol misuse
• are very underweight
• are taking other medications

Don’t take tylenol if you’ve had an allergic reaction to acetaminophen (paracetamol) in the past.

Before taking tylenol (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.

Tylenol dosage

Tylenol for children

Tylenol is a common painkiller for children. It’s used to treat most kinds of childhood ailments, including headache, tummy ache, earache, and cold symptoms. Tylenol can also be used to reduce fever 100.4 °F (38 °C) or above.

For older children, tylenol is available as tablets.

For young children, tylenol comes as a syrup.

Tylenol is also available as suppositories (a plug of medicine that’s inserted into the back passage). Suppositories are useful to relieve pain and fever in children who find it difficult to swallow tablets or syrup, or who are vomiting a lot.

For children aged 16 and over, read the information on tylenol for adults.

Key facts

• Your child should start to feel better about 30 minutes after taking tylenol tablets or syrup. It may take up to an hour for a suppository to work properly.
• Tylenol comes in a range of different strengths, so always use the measuring device that comes with the medicine. The right dose for your child depends on their age. Always leave 4 to 6 hours between doses. Don’t give more than 4 doses in 24 hours.
• Don’t give your child tylenol with other medicines containing tylenol, such as Children’s Tylenol Cold + Cough + Runny Nose Oral Suspension (only suitable for children 6 to 11 years).
• Tylenol is an everyday medicine, but it can be dangerous if too much is taken. Be careful to keep it out of the reach of children.

Who can and can’t take Tylenol

Children can take tylenol as:

• a liquid syrup – from the age of 3 months (2 months if they have a fever after a vaccination)
• suppository – from the age of 3 months (2 months if they have a fever after a vaccination)
• tablets – from the age of 6 years (500mg so they may need to be broken)
• soluble tablets – from the age of 12 years

Check with your doctor or pharmacist if your child:

• is small for their age as a lower dose may be better
• has had liver or kidney problems
• takes medicine for epilepsy
• takes medicine for tuberculosis (TB)

Giving tylenol with other painkillers

The only safe painkiller to give children alongside tylenol is ibuprofen.

• Do not give tylenol and ibuprofen together, though. Instead, if you’ve given them tylenol and they’re still feverish or in pain when the next dose is due, you could try ibuprofen instead.
• Don’t take more than the maximum daily dose of either medicine. See your doctor if you’ve tried both tylenol and ibuprofen and they haven’t helped. Do not give ibuprofen to your child if they have asthma, unless your doctor has said it’s okay.
• Don’t give your child another medicine with tylenol in it. If they take 2 different medicines that contain tylenol, there’s a risk of overdose. Tylenol is an ingredient in lots of medicines that you can buy from the supermarket or pharmacy.
• Never give aspirin to a child under the age of 16 (unless prescribed by a doctor).

Never give aspirin to a child under the age of 16 (unless prescribed by a doctor).

Tylenol for Children Uses

Temporarily:

• reduces fever
• relieves minor aches and pains due to:
• the common cold
• flu
• headache
• sore throat
• toothache

Tylenol for Children Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes:

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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.

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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin. Long-term use of acetaminophen may increase the effect of warfarin, which can increase the risk of bleeding. However, this is unlikely to happen with the occasional use of acetaminophen.

When using this product, do not exceed recommended dose.

Stop use and ask a doctor if:

• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

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

Infant tylenol dosage

Infants’ TYLENOL Oral Suspension

Active ingredient: Acetaminophen 160 mg in each 5 mL

Inactive ingredients:

• Cherry: anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Grape: anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Dye-Free Cherry: anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Infant tylenol directions of use

• do not take more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find the right dose on chart below. If possible, use weight to dose; otherwise, use age
• push air out of syringe. Insert syringe tip into the bottle opening
• flip bottle upside down. Pull yellow part of syringe to the correct dose
• dispense liquid slowly into child’s mouth, toward inner cheek
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• replace cap tightly to maintain child resistance

Table 1. Infant tylenol dosage chart

*or as directed by a doctor

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Other information: store between 20-25°C (68-77°F)

Do I need to keep paracetamol syrup in the fridge?

No, you don’t need to put paracetamol syrup in the fridge. Keep it in a cupboard away from heat and sunlight.

Children’s tylenol dosage

Children’s TYLENOL Oral Suspension

Active ingredient: Acetaminophen 160 mg in each 5 mL

Inactive ingredients:

• Cherry: anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, butylparaben, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Grape: anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum or anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Bubblegum: anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Strawberry: anhydrous citric acid, FD&C red no. 40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
• Dye-Free Cherry: anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Children’s tylenol directions of use

• this product does not contain directions or complete warnings for adult use
• do not take more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find the right dose on the chart below. If possible, use weight to dose; otherwise, use age
• remove the child protective cap and squeeze your child’s dose into the dosing cup
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Table 2. Children’s tylenol dosage chart

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information:

• each 5 mL contains: sodium 2 mg (Cherry, Grape, Bubblegum & Strawberry)
• each 5 mL contains: potassium 5 mg (Dye-Free Cherry only)
• store between 20-25° (68-77°F)

Do I need to keep paracetamol syrup in the fridge?

No, you don’t need to put paracetamol syrup in the fridge. Keep it in a cupboard away from heat and sunlight.

Is there any food or drink they need to avoid?

Your child can eat and drink normally while taking paracetamol.

You can give your child paracetamol on an empty stomach.

What if my child vomits?

• If your child vomits less than 30 minutes after having a dose of tylenol tablets or syrup, give them the same dose again.
• If your child vomits more than 30 minutes after a dose of tablets or syrup, you do NOT need to give them another dose. Wait until the next normal dose.

If your child is finding it hard to keep tablets or syrup down, ask your doctor if acetaminophen (paracetamol) suppositories are an option. If they vomit straight after a suppository, you don’t need to give them another dose as the suppository will still work.

What if they take too much?

Giving your child too much tylenol by accident can be dangerous. The effects of an overdose may not be obvious, but they can be serious and need treatment.

If you think you may have given your child an extra dose of tylenol by mistake, wait at least 24 hours before giving them any more.

If you think you may have given your child more than the recommended total daily dose of paracetamol, seek advice immediately, even if your child feels well. Go to your nearest hospital emergency department and seek urgent medical attention.

If you need to take your child to hospital, take the tylenol packet or leaflet inside it plus any remaining medicine with them.

Tylenol for adults

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

It’s 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

• Tylenol takes up to an hour to work.
• The usual dose of tylenol is one or two 500mg tablets at a time.
• Don’t take tylenol with other medicines containing tylenol.
• Tylenol is safe to take in pregnancy and while breastfeeding, at recommended doses.
• Tylenol is widely available as tablets and capsules. For people who find it difficult to swallow tablets or capsules, tylenol is also available as soluble tablets that dissolve in water to make a drink and as a syrup.

Who can and can’t take tylenol

Most people can take tylenol safely, including pregnant and breastfeeding women.

However, some people need to take extra care with tylenol.

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 tylenol on a regular basis.

Tylenol for Adults Uses

• Temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
• Temporarily reduces fever

Tylenol for Adults Warnings

Liver warning

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product

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.

Do NOT use

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Long-term use of acetaminophen may increase the effect of warfarin, which can increase the risk of bleeding. However, this is unlikely to happen with the occasional use of acetaminophen.

Stop use and ask a doctor if:

• pain gets worse or lasts more than 10 days
• fever gets worse or lasts more than 3 days
• new symptoms occur
• redness or swelling is present

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.

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

How many tylenol can I take?

The usual dose for adults is one or two 500mg tablets up to 4 times in 24 hours.

Always leave at least 4 hours between doses.

Overdosing on tylenol can cause serious side effects. Don’t be tempted to increase the dose or take a double dose if your pain is very bad.

• The total maximum dose of paracetamol for an adult is eight 500mg tablets in 24 hours. Wait at least 4 hours between doses.

Adult dose (over-16s only)

• Total maximum dose of paracetamol for an adult is eight 500mg tablets in 24 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
  • take one to two 500mg caplets while symptoms last, wait 4-6 hours
• do NOT take more than 6 caplets in 24 hours, unless directed by a doctor
• do NOT take for more than 10 days unless directed by a doctor

Tylenol max dose (over-16s only)

• 8 x 500 mg = 4,000 mg in 24 hours

What if I take too much?

Taking one or 2 extra tablets by accident is unlikely to be harmful. Wait at least 24 hours before you take any more tylenol.

Taking more than 2 extra tylenol tablets can be dangerous and may need treatment.

If you have taken more than the recommended total daily dose of paracetamol, seek advice immediately, even if you feel well. Go to your nearest hospital emergency department and seek urgent medical attention.

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

What if I forget to take it?

If you take tylenol regularly and miss a dose, take it as soon as you remember. If it’s close to the time for your next dose when you remember, then skip the missed dose.

Never take double doses of tylenol. Never take extra doses to catch up.

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.

Taking tylenol with other painkillers

It’s safe to take tylenol with other types of painkiller that don’t contain tylenol, such as ibuprofen, aspirin and codeine.

Don’t take tylenol alongside other medicines that contain tylenol. If you take 2 different medicines that contain tylenol, there’s a risk of overdose.

Pharmacy remedies that contain tylenol include some:

• migraine remedies
• cough and cold products

Tylenol may also be combined with other painkillers in medicines that have been prescribed by your doctor, such as:

• co-codamol (tylenol and codeine)
• co-dydramol (tylenol and dihydrocodeine)
• tramacet (tylenol and tramadol)

How should tylenol be used?

Acetaminophen comes as a tablet, chewable tablet, capsule, suspension or solution (liquid), extended-release (long-acting) tablet, and orally disintegrating tablet (tablet that dissolves quickly in the mouth), to take by mouth, with or without food. Acetaminophen also comes as a suppository to use rectally. Acetaminophen is available without a prescription, but your doctor may prescribe acetaminophen to treat certain conditions. Follow the directions on the package or prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

If you are giving acetaminophen to your child, read the package label carefully to make sure that it is the right product for the age of the child. Do not give children acetaminophen products that are made for adults. Some products for adults and older children may contain too much acetaminophen for a younger child. Check the package label to find out how much medication the child needs. If you know how much your child weighs, give the dose that matches that weight on the chart. If you don’t know your child’s weight, give the dose that matches your child’s age. Ask your child’s doctor if you don’t know how much medication to give your child.

Acetaminophen comes in combination with other medications to treat cough and cold symptoms. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold 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.

Swallow the extended-release tablets whole; do not split, chew, crush, or dissolve them.

Place the orally disintegrating tablet (‘Meltaways’) in your mouth and allow to dissolve or chew it before swallowing.

Shake the suspension well before each use to mix the medication evenly. Always use the measuring cup or syringe provided by the manufacturer to measure each dose of the solution or suspension. Do not switch dosing devices between different products; always use the device that comes in the product packaging.

Taking tylenol with other medicines, food and alcohol

Tylenol can react unpredictably with certain other medications. This can affect how well either medicine works and might increase the risk of side effects.

It may not be safe to take tylenol at the same time as:

• other products containing tylenol – including combination products where tylenol is one of the ingredients
• carbamazepine – used to treat epilepsy and some types of pain
• colestyramine – used to reduce itchiness caused by primary biliary cirrhosis (a type of liver disease)
• imatinib and busulfan – used to treat certain types of cancer
• ketoconazole – a type of antifungal medicine
• lixisenatide – used to treat type 2 diabetes
• metoclopramide – used to relieve nausea and vomiting
• phenobarbital, phenytoin and primidone – used to control seizures
• warfarin – used to prevent blood clots

Check the leaflet that comes with your medicine to see if it can be taken with tylenol. Ask a pharmacist or doctor if you’re not sure.

There are no known problems caused by taking tylenol with any specific foods or by drinking moderate amounts of alcohol while taking tylenol.

Tylenol side effects

Tylenol (acetaminophen) may cause side effects, but side effects from tylenol are rare, but can include:

• an allergic reaction, which can cause a rash and swelling
• flushing, low blood pressure and a fast heartbeat – this can sometimes happen when tylenol is given in hospital into a vein in your arm
• blood disorders, such as thrombocytopenia (low number of platelet cells) and leukopenia (low number of white blood cells)
• liver and kidney damage if you take too much (overdose) – this can be fatal in severe cases

Speak to a pharmacist or doctor if you develop any troublesome side effects that you think could be caused by tylenol.

Some side effects of tylenol can be serious. If you experience any of the following symptoms, stop taking tylenol and call your doctor immediately or get emergency medical attention:

• getting a skin rash that may include itchy, red, swollen, blistered or peeling skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing

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

Human Exposure and Toxicity

Nausea, vomiting, and abdominal pain usually occur within 2-3 hours after ingestion of toxic doses of the drug acetaminophen. In severe poisoning, central nervous system (CNS) stimulation, excitement, and delirium may occur initially. This may be followed by CNS depression, stupor, hypothermia, marked prostration, rapid shallow breathing, rapid weak irregular pulse, low blood pressure, and circulatory failure. When an individual has ingested a toxic dose of acetaminophen, the individual should be hospitalized for several days of observation, even if there are no apparent ill effects, because maximum liver damage and/or cardiotoxic effects usually do not become apparent until 2-4 days after ingestion of the drug. Other symptoms of acute poisoning include cerebral edema and nonspecific myocardial depression. Vascular collapse results from the relative hypoxia and from a central depressant action that occurs only with massive doses. Shock may develop if vasodilation is marked. Fatal seizures may occur. Coma usually precedes death, which may occur suddenly or may be delayed for several days. Biopsy of the liver reveals centralobular necrosis with sparing of the periportal area. There have been reports of acute myocardial necrosis and pericarditis in individuals with acetaminophen poisoning. Hypoglycemia, which can progress to coma have been reported in patients ingesting toxic doses of acetaminophen. Low prothrombin levels and thrombocytopenia have been reported in patients with acetaminophen poisoning. Skin reactions of an erythematous or urticarial nature which may be accompanied by fever and oral mucosal lesions also have been reported. For use anytime during pregnancy, 781 exposures were recorded, and possible associations with congenital dislocation of the hip (eight cases) and clubfoot (six cases) were found. There is inadequate evidence in humans for the carcinogenicity of acetaminophen.

Evidence for Carcinogenicity

There is inadequate evidence in humans for the carcinogenicity of paracetamol. There is inadequate evidence in experimental animals for the carcinogenicity of paracetamol ². Overall evaluation: Paracetamol is not classifiable as to its carcinogenicity to humans (Group 3) ².

Animal Toxicity Studies

Concern has been raised over chemical-induced disruption of ovary development during fetal life resulting in long-lasting consequences only manifesting themselves much later during adulthood. A growing body of evidence suggests that prenatal exposure to the mild analgesic acetaminophen/paracetamol can cause such a scenario ³. In a review of three recent reports that collectively indicate that prenatal exposure in a period of 13.5 days post coitum in both rats and mouse can result in reduced female reproductive health. The combined data show that the exposure results in the reduction of primordial follicles, irregular menstrual cycle, premature absence of corpus luteum, as well as reduced fertility, resembling premature ovarian insufficiency syndrome in humans that is linked to premature menopause ³. This could especially affect the Western parts of the world, where the age for childbirth is continuously being increased and acetaminophen is recommended during pregnancy for pain and fever ³. The study authors highlight an urgent need for more studies to verify these data including both experimental and epidemiological approaches ³.

There is inadequate evidence in experimental animals for the carcinogenicity of acetaminophen. In rats fasted 24 hours and given a single dose of acetaminophen (2 g/kg) by gavage, liver necrosis around the central vein was noted at 9-12 hours and was much more extensive at 24 hours after treatment. In mice after dietary exposure to acetaminophen up to 6400 mg/kg daily for 13 weeks hepatotoxicity, organ weight changes and deaths were observed. Cats are particularly susceptible to acetaminophen intoxication, developing more diffuse liver changes, while hepatic centrilobular lesions found in dogs. High doses of acetaminophen caused testicular atrophy and delay in spermiogenesis in mice. Furthermore, reductions in the fertility and neonatal survival in mice were seen in the F0 generation and decreases in F1 pup weights were found at acetaminophen dose 1430 mg/kg. Acetaminophen was not mutagenic in Salmonella typhimurium assay with or without metabolic activation in six strains: TA1535, TA1537, TA1538, TA100, TA97 and TA98. In vitro and animal data indicate that small quantities of acetaminophen are metabolized by a cytochrome P-450 microsomal enzyme to a reactive intermediate metabolite (N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI) which is further metabolized via conjugation with glutathione and ultimately excreted in urine as a mercapturic acid. It has been suggested that this intermediate metabolite is responsible for acetaminophen-induced liver necrosis in cases of overdose. Excipients found in liquid formulations of acetaminophen may decrease its liver toxicity.

Ecotoxicity Studies

Daphnia magna was the most susceptible among the test organisms to the environmental effects of acetaminophen. Acetaminophen has recently been identified as a promising snake toxicant to reduce brown tree snake populations on Guam, while posing only the minimal risks to non-target rodents, cats, pigs and birds.

Tylenol poisoning

Acetaminophen toxicity may result from a single toxic dose, from repeated ingestion of large doses of acetaminophen (e.g., 7.5-10 g daily for 1-2 days), or from chronic ingestion of the drug ⁴. Dose-dependent, hepatic necrosis is the most serious acute toxic effect associated with overdosage and is potentially fatal ⁴.

A case report of oral acetaminophen toxicity in a term newborn infant successfully treated with a 20 hr intravenous N-acetylcysteine infusion protocol without any adverse effects. This case report supports the use of N-acetylcysteine to treat neonatal acetaminophen toxicity ⁵.

A 3.5 yr old girl with an upper respiratory infection died of an acetaminophen overdose ⁶. When the child’s temperature remained elevated after treatment with 120 mg every 4 hr for 3 doses, dosage was increased to 720 mg every 3 hr. Over the next 24 hr the patient received 5.04 g ⁶.

A 63 yr old man with acute psittacosis had severe hepatic damage after ingesting about 10 g acetaminophen over a 48 hr period. Transaminase levels showed striking elevation, with a serum glutamic-oxaloacetic transaminase level of over 15000 iu/L, and decreased rapidly, consistent with toxic insult. The liver showed severe central necrosis at autopsy ⁷.

An 18-year-old woman, gravida 1, presented at 33 weeks’ gestation with signs and symptoms consistent with acute fatty liver of pregnancy and fetal death. Markedly elevated transaminases prompted a search for other etiologies, and acetaminophen toxicity was diagnosed. Liver biopsy revealed acute fatty liver of pregnancy and toxin-induced injury consistent with acetaminophen use. The patient’s condition deteriorated, resulting in fulminant hepatic failure and requiring postpartum orthotopic liver transplantation. The combination of acute fatty liver of pregnancy and acetaminophen toxicity resulted in acute liver failure ⁸.

A case involving a 22-year-old woman in her 31st week of pregnancy who consumed a 15 g dose of acetaminophen, followed by a 50 g dose 1 week later is reported ⁹. Fetal distress was observed 16 hours after the second overdose, as evidenced by complete lack of fetal movements and breathing, a marked decrease in fetal heart rate beat-to-beat variability with no accelerations, and a falling baseline rate. Because of the fetal condition, labor was induced (cesarean section was excluded because of the mothers incipient hepatic failure). Eighty-four hours after the overdose, a 2198 g female infant was delivered with an Apgar scores at 1 and 5 min of 9 and 10, respectively. Except for hypoglycemia, mild respiratory disease, and mild jaundice, the newborn did well. Liver enzymes were always within normal range, and the jaundice was compatible with immaturity. Acetaminophen was not detected in the cord blood. Follow-up examinations of the infant at 6 weeks and again at 6 months were normal. Protection against serious or permanent liver damage was probably afforded by the prompt administration of iv N-acetylcysteine ⁹.

Nausea, vomiting, and abdominal pain usually occur within 2-3 hours after ingestion of toxic doses of the drug. Unlike aspirin, acetaminophen does not usually cause acid/base changes in toxic doses ⁴. In severe poisoning, CNS stimulation, excitement, and delirium may occur initially. This may be followed by CNS (central nervous system) depression; stupor; hypothermia; marked prostration; rapid, shallow breathing; rapid, weak, irregular pulse; low blood pressure; and circulatory failure. Vascular collapse results from the relative hypoxia and from a central depressant action that occurs only with massive doses. Shock may develop if vasodilation is marked. Fatal asphyxial seizures may occur. Coma usually precedes death, which may occur suddenly or may be delayed for several days ⁴.

Acetaminophen toxicity usually involves 4 phases ⁴:

1. Anorexia, nausea, vomiting, malaise, and diaphoresis (which inappropriately may prompt administration of additional acetaminophen);
2. Resolution of phase-1 manifestations and replacement with right upper quadrant pain or tenderness, liver enlargement, elevated bilirubin and hepatic enzyme concentrations, prolongation of prothrombin time, and occasionally oliguria;
3. Anorexia, nausea, vomiting, and malaise recur (usually 3-5 days after initial symptom onset) and signs of hepatic failure (e.g., jaundice, hypoglycemia, coagulopathy, encephalopathy) and possibly renal failure and cardiomyopathy develop; and
4. Recovery or progression to fatal complete liver failure.

Three hundred and seven cases of liver injury associated with acetaminophen use were reported to the US Food and Drug Administration (FDA) from January 1998 to July 2001 ¹⁰. Sixty percent of these adverse events were categorized as severe life-threatening injury with liver failure (category 4); 40% of patients died. Review of these case reports indicates that use of higher than recommended daily dosages of acetaminophen results in adverse hepatotoxic effects more often than use of recommended dosages ¹⁰.

The Rocky Mountain Poison and Drug Center ⁹ reported the results of a nationwide study on acetaminophen overdose during pregnancy involving 113 women. Of the 60 cases that had appropriate laboratory and pregnancy outcome data, 19 occurred in the 1st trimester, 22 during the 2nd trimester, and 19 during the 3rd trimester. In those cases with a potentially toxic serum level of acetaminophen, early treatment with N-acetylcysteine was statistically associated with an improved pregnancy outcome by lessening the incidence of spontaneous abortion and fetal death ⁹. Only one congenital anomaly was observed in the series and that involved a 3rd trimester overdose with nontoxic maternal acetaminophen serum levels ⁹.

Very high levels of acetaminophen can cause lactic acidosis and altered mental status by uncertain mechanisms, probably involving mitochondrial dysfunctin ¹¹. Symptoms of acute acetaminophen poisoning both metabolic acidosis and metabolic alkalosis have been noted; cerebral edema & nonspecific myocardial depression have also occurred ¹². Biopsy of the liver reveals centralobular necrosis with sparing of the periportal area ¹².

Low prothrombin levels have been reported in patients with acetaminophen poisoning and in one patient fatal GI hemorrhage was attributed to hypoprothrombinemia. Thrombocytopenia also has been reported. Toxic doses of p-aminophenol derivatives may produce skin reactions of an erythematous or urticarial nature which may be accompanied by fever and oral mucosal lesions ¹³.

Eighty-eight patients with acetaminophen-induced acute liver failure were recruited ¹⁴. Control groups included patients with nonacetaminophen-induced acute liver failure (n = 13), nonhepatic multiple organ failure (n = 28), chronic liver disease (n = 19), and healthy controls (n = 11). Total and caspase-cleaved cytokeratin-18 (M65 and M30) measured at admission and sequentially on days 3, 7, and 10 following admission. Levels were also determined from hepatic vein, portal vein, and systemic arterial blood in seven patients undergoing transplantation. Protein arrays of liver homogenates from patients with acetaminophen-induced acute liver failure were assessed for apoptosis-associated proteins, and histological assessment of liver tissue was performed. Admission M30 levels were significantly elevated in acetaminophen-induced acute liver failure and non-acetaminophen induced acute liver failure patients compared with multiple organ failure, chronic liver disease, and healthy controls. Admission M30 levels correlated with outcome with area under receiver operating characteristic of 0.755. Peak levels in patients with acute liver failure were seen at admission then fell significantly but did not normalize over 10 days. A negative gradient of M30 from the portal to hepatic vein was demonstrated in patients with acetaminophen-induced acute liver failure at the time of liver transplant. Analysis of protein array data demonstrated lower apoptosis-associated protein and higher catalase concentrations in acetaminophen-induced acute liver failure compared with controls. Explant histological analysis revealed evidence of cellular proliferation with an absence of histological evidence of apoptosis. Hepatocellular apoptosis occurs in the early phases of human acetaminophen-induced acute liver failure, peaking on day 1 of hospital admission, and correlates strongly with poor outcome. Hepatic regenerative/tissue repair responses prevail during the later stages of acute liver failure where elevated levels of M30 are likely to reflect epithelial cell death in extrahepatic organs ¹⁴.

The U.S. Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal ¹⁵. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. … Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away. Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers. Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions.

Tylenol 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.

Can you overdose on Tylenol?

Yes. Taking too much tylenol, known as an overdose, can be very dangerous.

If you’ve taken more than the recommended maximum dose, go to your nearest accident and emergency (A&E) department as soon as possible.

It can be helpful to take any remaining medicine and the box or leaflet with you to a hospital accident and emergency department if you can.

Some people feel sick, vomit or have abdominal (tummy) pain after taking too much tylenol, but often there are no obvious symptoms at first.

• Go to a hospital accident and emergency department even if you’re feeling well.

When an individual has ingested a toxic dose of acetaminophen, the individual should be hospitalized for several days of observation, even if there are no apparent ill effects, because maximum liver damage usually does not become apparent until 2-4 days after ingestion of the drug ¹³. Transient azotemia and renal tubular necrosis have been reported in patients with acetaminophen poisoning; renal failure is often associated with fatality. There have been reports of acute myocardial necrosis and pericarditis in individuals with acetaminophen poisoning. Maximum cardiotoxic effects of these drugs appear to be delayed in a manner similar to hepatotoxic effects. Hypoglycemia, which can progress to coma, and metabolic acidosis have been reported in patients ingesting toxic doses of acetaminophen and cerebral edema occurred in one patient ¹³.

In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Plasma acetaminophen levels > 300 ug/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 ug/mL or < 37.5 ug/mL at 12 hours after ingestion. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion ¹⁶.

1. Trettin A, Böhmer A, Suchy M-T, et al. Effects of Paracetamol on NOS, COX, and CYP Activity and on Oxidative Stress in Healthy Male Subjects, Rat Hepatocytes, and Recombinant NOS. Oxidative Medicine and Cellular Longevity. 2014;2014:212576. doi:10.1155/2014/212576. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3988730/
2. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. http://monographs.iarc.fr/ENG/Classification/index.php
3. Is exposure during pregnancy to acetaminophen/paracetamol disrupting female reproductive development? Endocr Connect. 2018, Jan; 7(1):149-158.
4. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2209
5. Walls L et al; J Perinatol 27 (2): 133-5; 2007
6. Nogen A, Bremmer J; J Pediatr 92 (MAY): 832; 1978
7. Davis AM et al; Am J Med 74 (2): 349; 1983
8. Gill EJ t al; J Reprod Med 47 (7): 584-6; 2002
9. Briggs, G.G., Freeman, R.K., Yaffee, S.J.; Drugs in Pregancy and Lactation Nineth Edition. Wolters Kluwer/Lippincott Williams & Wilkins, Philadelphia, PA. 2011, p. 9
10. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2211
11. OLSON, K.R. (Ed). Poisoning and Drug Overdose, Sixth Edition. McGraw-Hill, New York, NY 2012, p. 69
12. Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 704
13. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 2210
14. Possamai LA et al; Crit Care Med 41 (11): 2543-50; 2013
15. US FDA; FDA Drug Safety Communication: FDA Warns of Rare but Serious Skin Reactions with the Pain Reliever/Fever Reducer Acetaminophen. https://www.fda.gov/drugs/drugsafety/ucm363041.htm
16. US Natl Inst Health; DailyMed. Current Medication Information for OFIRMEV (acetaminophen) injection, solution (October 2013). Available from, as of March 6, 2014

What is benadryl

Benadryl is a medicine that relieves allergy that contain an active ingredient called Diphenhydramine, which is an antihistamine [histamine-1 (H1) receptor blocker or antagonist] that reduces the effects of natural chemical histamine in your body. Histamine is a chemical that’s released by Mast cells in your body when an allergen is encountered that can produce symptoms of sneezing, hives, itching, watery eyes, and runny nose, also known as hypersensitivity reactions.

Benadryl (Diphenhydramine) is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Benadryl (Diphenhydramine) is also used to relieve cough caused by minor throat or airway irritation. Benadryl (Diphenhydramine) is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Benadryl (Diphenhydramine) is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication.

Benadryl (Diphenhydramine) will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Benadryl (Diphenhydramine) should not be used to cause sleepiness in children. Benadryl (Diphenhydramine) is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Like other antihistamines, Benadryl (Diphenhydramine) should be used with caution in infants and young children and should NOT be used in premature or full-term neonates ¹. Children younger than 6 years of age should receive Benadryl (Diphenhydramine) only under the direction of a physician ¹. Safety and efficacy of Benadryl (Diphenhydramine) as a nighttime sleep aid in children younger than 12 years of age have not been established ¹. In addition, children may be more prone than adults to paradoxically experience CNS stimulation rather than sedation when antihistamines are used as nighttime sleep aids ¹. Because Benadryl (Diphenhydramine) may cause marked drowsiness that may be potentiated by other CNS depressants (e.g., sedatives, tranquilizers), the antihistamine should be used in children receiving one of these drugs only under the direction of a physician ¹.

Because Benadryl (Diphenhydramine) has an atropine-like action, it should be used with caution in patients who have asthma ². Patients should be cautioned about taking Benadryl (Diphenhydramine) with other depressant substances, because of the additive effect. Persons should also be advised not to operate a motor vehicle, fly an airplane, or operate hazardous machinery while on this drug. The incidence of side effects is approximately 30-60% ².

The most frequent side effect of Benadryl (Diphenhydramine) the first-generation H1 antagonists is sedation. Although sedation may be a desirable adjunct in the treatment of some patients, it may interfere with the patient’s daytime activities ³. Concurrent ingestion of alcohol or other CNS depressants produces an additive effect that impairs motor skills. Other untoward reactions referable to central actions include dizziness, tinnitus, lassitude, incoordination, fatigue, blurred vision, diplopia, euphoria, nervousness, insomnia, and tremors.

What does Benadryl do

Benadryl (Diphenhydramine) is a first generation antihistamine with sedative and anti-allergic properties. Benadryl (Diphenhydramine) competitively inhibits the histamine-1 (H1) receptor, thereby alleviating the symptoms caused by endogenous histamine on bronchial, capillary and gastrointestinal smooth muscles. This prevents histamine-induced bronchoconstriction, vasodilation, increased capillary permeability, and gastrointestinal smooth muscle spasms.

Benadryl is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching (pruritus), and other cold or allergy symptoms.

Benadryl is also used to treat motion sickness as an antiemetic, antitussive, to induce sleep, and to treat certain symptoms (e.g. tremors) of Parkinson’s disease (off-label use).

Benadryl ingredients

Benadryl active ingredient: Diphenhydramine HCl 25 mg

Ingredient Purpose: Antihistamine

Inactive Ingredients

• carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Benadryl and alcohol

Ask your doctor before using Benadryl together with ethanol. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking Benadryl. Using Benadryl together with alcohol increases your risk for overdose. You should be warned not to exceed recommended dosages and to avoid activities requiring mental alertness. If your doctor prescribes these medications together, you may need a dose adjustment to safely take this combination. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Benadryl Pregnancy Warnings

Animal models have failed to reveal evidence of impaired fertility or fetal harm at doses up to 5 times the human dose. There are no controlled data in human pregnancy.

• US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use is recommended only if clearly needed and the benefit outweighs the risk.

I just found out I am pregnant. Should I stop taking Benadryl?

You should always talk with your health care provider before making any changes in your medication. It is important to consider the benefits of treating allergy symptoms and other conditions during pregnancy. Treating allergy symptoms may reduce asthma symptoms and the need for more asthma medicine. Allergy treatment can also result in better sleep and emotional well-being.

Can use of Benadryl during pregnancy cause birth defects?

It is unlikely that Benadryl (Diphenhydramine) would cause an increased chance for birth defects. Most studies show no increased chance of birth defects with the use of Benadryl (Diphenhydramine) in early pregnancy. While one study suggested an increased chance of several types of birth defects, the study does not prove causation and these findings have not been confirmed.

Can use of Benadryl cause other pregnancy complications?

At recommended doses, Benadryl (Diphenhydramine) has not been shown to cause problems in pregnancy. There are rare reports of problems with the use of Benadryl (Diphenhydramine) in the third trimester. These reports usually involve using more of the medication than is recommended or using it for long-term (chronic) use. High levels of Benadryl (Diphenhydramine) could cause uterine hyperstimulation (contractions that are too long or too often). Uterine hyperstimulation can affect the developing baby such as increasing the baby’s heart rate. Uterine contractions can also lead to serious complications, including uterine rupture (a tear in the uterus) or placental abruption (when the placenta pulls away from the wall of the uterus before the baby is born).

Also, there are a few reports of withdrawal symptoms in infants whose mothers took Benadryl (Diphenhydramine) daily throughout pregnancy.

Is there anyone who should avoid taking Benadryl during pregnancy?

A single human report and animal data have suggested that the combination of two medications: temazepam (a benzodiazepine) and Benadryl (Diphenhydramine) may increase the chance for stillbirth or infant death shortly after birth ⁴. It is unknown if this interaction will occur with all medications in the benzodiazepine class. Women taking benzodiazepines should talk with their health care provider before taking Benadryl (Diphenhydramine) during their pregnancy ⁴.

Benadryl and Breastfeeding

Benadryl (Diphenhydramine) has been detected in milk ¹. Because of the potential for serious adverse reactions to antihistamines in nursing infants, a decision should be made whether to discontinue nursing or Benadryl (Diphenhydramine), taking into account the importance of the drug to the woman.

Because Benadryl (Diphenhydramine) can cause sleepiness in adults, it may do the same for the baby ⁵. If you need to take an antihistamine regularly, ask your health care provider if a non-sedating one would work for your symptoms.

Antihistamines, as a group, might lower the amount of milk a woman makes, especially when using long acting antihistamines ⁶ and when used with decongestants like pseudoephedrine or phenylephrine. This is less likely to be of concern in a woman with established milk supply (has been breastfeeding for a while).

Two studies ⁷ with women who used an antihistamine (not just Benadryl) while breastfeeding reported their babies were irritable, sleepier, and/or slept less.

Be sure to discuss any medications you are taking and your options for breastfeeding with your health care provider as well as the baby’s pediatrician.

What is Benadryl used for

Benadryl uses

• Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • Runny nose
  • Sneezing
  • Itchy, watery eyes
  • Itching of the nose or throat
• Temporarily relieves these symptoms due to the common cold:
  • Runny nose
  • Sneezing

How should Benadryl be used?

Benadryl (Diphenhydramine) comes as a tablet, a rapidly disintegrating (dissolving) tablet, a capsule, a liquid-filled capsule, a dissolving strip, powder, and a liquid to take by mouth. When Benadryl (Diphenhydramine) is used for the relief of allergies, cold, and cough symptoms, it is usually taken every 4 to 6 hours. When Benadryl (Diphenhydramine) is used to treat motion sickness, it is usually taken 30 minutes before departure and, if needed, before meals and at bedtime. When Benadryl (Diphenhydramine) is used to treat insomnia it is taken at bedtime (30 minutes before planned sleep). When Benadryl (Diphenhydramine) is used to treat abnormal movements, it is usually taken three times a day at first and then taken 4 times a day. Follow the directions on the package or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Benadryl (Diphenhydramine) exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or directed on the label.

Benadryl (Diphenhydramine) comes alone and in combination with pain relievers, fever reducers, and decongestants. Ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold 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 Benadryl (Diphenhydramine), 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 Benadryl (Diphenhydramine) or a combination product that contains Benadryl (Diphenhydramine) 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 Benadryl (Diphenhydramine) products that are made for adults to children.

Before you give a Benadryl (Diphenhydramine) 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.

If you are taking the liquid, do not use a household spoon to measure your dose. Use the measuring spoon or cup that came with the medication or use a spoon made especially for measuring medication.

If you are taking the dissolving strips, place the strips on your tongue one at a time and swallow after they melt.

If you are taking the rapidly dissolving tablets, place a tablet on your tongue and close your mouth. The tablet will quickly dissolve and can be swallowed with or without water.

If you are taking the capsules, swallow them whole. Do not try to break the capsules.

What should I do if I forget a dose?

Benadryl (Diphenhydramine) is usually taken as needed. If your doctor has told you to take Benadryl (Diphenhydramine) regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Before taking Benadryl – Precautions

• tell your doctor and pharmacist if you are allergic to Benadryl (Diphenhydramine) 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: other Benadryl (Diphenhydramine) products (even those that are used on the skin); other medications for colds, hay fever, or allergies; medications for anxiety, depression, or seizures; muscle relaxants; narcotic medications for pain; sedatives; sleeping pills; and tranquilizers.
• tell your doctor if you have or have ever had asthma, emphysema, chronic bronchitis, or other types of lung disease; glaucoma (a condition in which increased pressure in the eye can lead to gradual loss of vision); ulcers; difficulty urinating (due to an enlarged prostate gland); heart disease; high blood pressure; seizures; or an overactive thyroid gland.If you will be using the liquid, tell your doctor if you have been told to follow a low-sodium diet.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Benadryl (Diphenhydramine), call your doctor.
• talk to your doctor about the risks and benefits of taking Benadryl (Diphenhydramine) if you are 65 years of age or older. Older adults should not usually take Benadryl (Diphenhydramine) because it is not as safe as other medications that can be used to treat the same conditions.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Benadryl (Diphenhydramine).
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. Avoid alcoholic beverages while you are taking this medication.
• 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 chewable tablets and rapidly disintegrating tablets that contain Benadryl (Diphenhydramine) may be sweetened with aspartame, a source of phenylalanine.
• Like other antihistamines, Benadryl (Diphenhydramine) should be used with caution in infants and young children and should not be used in premature or full-term neonates. Children younger than 6 years of age should receive Benadryl (Diphenhydramine) only under the direction of a physician. Safety and efficacy of Benadryl (Diphenhydramine) as a nighttime sleep aid in children younger than 12 years of age have not been established. In addition, children may be more prone than adults to paradoxically experience CNS stimulation rather than sedation when antihistamines are used as nighttime sleep aids. Because Benadryl (Diphenhydramine) may cause marked drowsiness that may be potentiated by other CNS depressants (e.g., sedatives, tranquilizers), the antihistamine should be used in children receiving one of these drugs only under the direction of a physician.

Benadryl dosage

Benadryl Allergy ULTRATAB Tablets Dosage

Benadryl Allergy ULTRATAB Tablets Ingredient: Diphenhydramine HCl 25 mg

How often can you take Benadryl Allergy ULTRATAB Tablets:

• Take every 4 to 6 hours, or as directed by a doctor
• Do NOT take more than 6 times in 24 hours
  • Adults and children 12 years and over: 1 to 2 tablets
  • Children 6 to under 12 years: 1 tablet
  • Children under 6 years: do NOT use

Other Information:

• Each tablet also contains: calcium 15 mg
• Store between 20-25° C (68-77° F). Protect from light.

Benadryl Allergy ULTRATAB Tablets WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• A breathing problem such as emphysema or chronic bronchitis
• Glaucoma
• Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• Marked drowsiness may occur
• Avoid alcoholic drinks
• Alcohol, sedatives, and tranquilizers may increase drowsiness
• Be careful when driving a motor vehicle or operating machinery
• Excitability may occur, especially in children

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.

Benadryl Allergy Plus Congestion Dosage

Benadryl Allergy Plus Congestion Ingredient: Diphenhydramine HCl 25 mg (Antihistamine) plus Phenylephrine HCl 10 mg (nasal decongestant)

Inactive Ingredients

• carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide

How often can you take Benadryl Allergy Plus Congestion tablets:

• Adults and children 12 years and over:
  • Take 1 tablet every 4 hours
  • Do not take more than 6 tablets in 24 hours
• Children under 12 years: Ask a doctor

Other Information:

• Store between 20-25° C (68-77° F).

Benadryl Allergy Plus Congestion Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat
• Nasal Congestion

Temporarily relieves these symptoms due to the common cold:

• Runny nose
• Sneezing
• Nasal Congestion

Temporarily relieves sinus congestion and pressure

Benadryl Allergy Plus Congestion WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin
• 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
• A breathing problem such as emphysema or chronic bronchitis
• Glaucoma

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• Do not exceed recommended dose
• Marked drowsiness may occur
• Avoid alcoholic drinks
• 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:

• Nervousness, dizziness, or sleeplessness occur
• Symptoms do not improve within 7 days or occur with a 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 Benadryl Allergy Liquid Dosage

Children’s Benadryl Allergy Liquid Ingredient: Diphenhydramine HCl 12.5 mg/5 mL

Inactive Ingredient:

• anhydrous citric acid, D&C red no. 33, FD&C red no. 40, flavors, glycerin, monoammonium glycyrrhizinate, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

How often can you take Children’s Benadryl Allergy Liquid:

mL = milliliter

• Take every 4 to 6 hours, or as directed by a doctor.
• Do not take more than 6 doses in 24 hours.
  • Children under 2 years: do NOT use.
  • Children 2 to 5 years: do NOT use unless directed by a doctor
  • Children 6 to 11 years: 5 mL to 10 mL

Attention: Use only the dosing cup specifically designed for use with this product. Do no use any other dosing device.

Other Information:

• Each 5 mL contains: sodium 14 mg.
• Store between 20-25° C (68-77° F).
• Protect from light. Store in outer carton until contents used.

Children’s Benadryl Allergy Liquid Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Children’s Benadryl Allergy Liquid WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• A breathing problem such as chronic bronchitis
• Glaucoma
• A sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product:

• Marked drowsiness may occur
• Sedatives and tranquilizers may increase drowsiness
• Excitability may occur, especially in children

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

Children’s Benadryl Dye-Free Allergy Liquid Dosage

Children’s Benadryl Dye-Free Allergy Liquid Ingredient: Diphenhydramine HCl 12.5 mg/5 mL

Inactive Ingredient:

• Anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

How often can you take Children’s Benadryl Dye-Free Allergy Liquid:

mL = milliliter

• Take every 4 to 6 hours, or as directed by a doctor.
• Do not take more than 6 doses in 24 hours.
  • Children under 2 years: do NOT use.
  • Children 2 to 5 years: do NOT use unless directed by a doctor
  • Children 6 to 11 years: 5 mL to 10 mL

Attention: Use only the dosing cup specifically designed for use with this product. Do no use any other dosing device.

Other Information:

• Each 5 mL contains:sodium 10 mg.
• Store between 20-25° C (68-77° F).

Children’s Benadryl Dye-Free Allergy Liquid Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• Runny nose
• Sneezing
• Itchy, watery eyes
• Itching of the nose or throat

Children’s Benadryl Dye-Free Allergy Liquid WARNINGS

Do NOT use

• To make a child sleepy
• With any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have:

• A breathing problem such as chronic bronchitis
• Glaucoma
• A sodium-restricted diet

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product:

• Marked drowsiness may occur
• Sedatives and tranquilizers may increase drowsiness
• Excitability may occur, especially in children

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

Benadryl side effects

The most commonly reported side effects included somnolence, dizziness, and incoordination.

Benadryl (Diphenhydramine) may cause side effects. Numerous side effects including drowsiness, confusion, restlessness, nausea, vomiting, diarrhea, blurring of vision, diplopia, difficulty in urination, constipation, nasal stuffiness, vertigo, palpitation, headache, and insomnia ². Other side effects observed were urticaria, drug rash, photosensitivity, hemolytic anemia, hypotension, epigastric distress, anaphylactic shock, tightness of the chest and wheezing, thickening of bronchial secretions, dryness of the mouth, nose and throat and tingling, and heaviness and weakness of the hands ².

Prolonged use of antihistamines … may decrease or inhibit salivary flow, thus contributing to the development of caries, periodontal disease, oral candidiasis, and discomfort ⁸.

Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth, nose, and throat
• drowsiness
• dizziness
• nausea
• vomiting
• loss of appetite
• constipation
• increased chest congestion
• headache
• muscle weakness
• excitement (especially in children)
• nervousness

Some side effects may be serious. If you experience any of the following symptoms, call your doctor immediately:

• vision problems
• difficulty urinating or painful urination

Benadryl (Diphenhydramine) may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.

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)

Common side effects

The most common side effect of Benadryl is feeling sleepy and tired. This happens in more than 1 in 10 people. Talk to your doctor or pharmacist if this side effect bothers you or won’t go away.

Other common side effects of Benadryl happen in more than 1 in 100 people. Talk to your doctor or pharmacist if these side effects bother you or won’t go away:

• dry mouth
• feeling dizzy

Common side effects of Benadryl mixed with pseudoephedrine happen in more than 1 in 100 people. They include:

• difficulty sleeping
• hallucinations
• rashes
• difficulty peeing in men – especially men with an enlarged prostate

Nervous system

• Common (1% to 10%): Sedation/somnolence/sleepiness, drowsiness, unsteadiness, dizziness, headache, attention disturbance
• Rare (0.01% to 0.1%): Extrapyramidal effects, tremor, convulsions
• Frequency not reported: Paresthesia, dyskinesia/muscle dyskinesia, vertigo, neuritis, incoordination, psychomotor impairment, activation of epileptogenic foci.

Drowsiness usually diminishes after a few days.

Gastrointestinal

• Common (1% to 10%): Dry mouth
• Frequency not reported: Gastrointestinal disturbance, nausea, vomiting, constipation, diarrhea, dyspepsia, epigastric distress

Other

• Common (1% to 10%): Fatigue
• Frequency not reported: Lassitude, tinnitus, acute labyrinthitis, asthenia, chills, impaired performance (including impaired driving, work, and/or information processing)

Psychiatric

• Rare (0.01% to 0.1%): Confusion, depression, sleep disturbances
• Frequency not reported: Paradoxical excitation/excitation, agitation, increased energy, restlessness, nervousness, euphoria, anxiety, hallucinations, insomnia, irritability

Cardiovascular

• Rare (0.01% to 0.1%): Palpitations, hypotension, arrhythmia
• Frequency not reported: Tachycardia, chest tightness, extrasystoles

Hematologic

• Rare (0.01% to 0.1%): Blood disorders
• Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis

Hypersensitivity

• Rare (0.01% to 0.1%): Hypersensitivity reactions
• Frequency not reported: Angioedema, anaphylactic shock

Hepatic

• Rare (0.01% to 0.1%): Liver dysfunction

Dermatologic

• Frequency not reported: Rash, urticaria, skin rashes, erythema, photosensitivity, pruritus, drug rash, excessive perspiration

Respiratory

• Frequency not reported: Dyspnea, thickening of bronchial secretions, throat tightening, wheezing, nasal stuffiness, dry nose or throat

Genitourinary

• Frequency not reported: Urinary hesitancy/difficulty/retention, dysuria, early menses

Ocular

• Frequency not reported: Blurred vision, dry eyes, diplopia

Metabolic

• Frequency not reported: Increased appetite, anorexia

Musculoskeletal

• Frequency not reported: Muscle twitching/weakness

Serious side effects

In rare cases, it’s possible to have a serious allergic reaction to Benadryl.

The warning signs of 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 Benadryl. For a full list see the leaflet inside your medicines packet.

How to cope with side effects

What to do about:

• feeling sleepy – try a different non-drowsy antihistamine. If this doesn’t help, talk to your doctor.
• dry mouth chew sugar-free gum or suck sugar-free sweets.
• feeling dizzy – lie down until the dizziness passes, then get up slowly. Move slowly and carefully. Avoid coffee, cigarettes, alcohol and recreational drugs. If the dizziness doesn’t get better within a couple of days, speak to your pharmacist or doctor.

Benadryl overdose

Overdose occurs when someone takes more than the normal or recommended amount of this medicine. This can be by accident or on purpose.

In case of overdose, get medical help or contact a Poison Control Center helpline at 1-800-222-1222 right away!

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.

Excessive doses may cause flushing, tachycardia, blurred vision, delirium, toxic psychosis, urinary retention, and respiratory depression ⁹.

Overdosage of diphenhydramine may result in the development of anticholinergic symptoms, seizures, and coma ¹⁰. A fatal outcome following a diphenhydramine overdose does not commonly occur. This report describes an overdosage of diphenhydramine (7.5 g) which resulted in the death of a 14-year-old girl ¹⁰. The patient initially developed seizures following by cardiac conduction and hemodynamic compromise resulting in death despite life support measures.

Symptoms of Benadryl Overdose

Below are symptoms of a Benadryl (Diphenhydramine) overdose in different parts of the body ¹¹.

Bladder and Kidneys

• Inability to urinate

Eyes, ears, nose, mouth and throat

• Blurred vision
• Dry mouth
• Enlarged pupils
• Very dry eyes
• Ringing in the ears

Heart and blood vessels

• Low blood pressure
• Rapid heartbeat

Nervous system

• Agitation
• Confusion
• Seizures
• Delirium
• Depression
• Drowsiness
• Hallucinations (seeing or hearing things that aren’t there)
• Increased sleepiness
• Nervousness
• Tremor
• Unsteadiness

Skin

• Dry, red skin

Stomach and intestines

• Nausea
• Vomiting

What to Expect at the Emergency Room

Take the container to the hospital with you, if possible.

The health care provider will measure and monitor the person’s vital signs, including temperature, pulse, breathing rate, and blood pressure.

Tests that may done include ¹²:

• Blood and urine tests
• Chest x-ray
• ECG (electrocardiogram or heart tracing)

Treatment may include ¹²:

• Fluids through a vein (by IV)
• Medicines to treat symptoms
• Activated charcoal
• Laxative
• Breathing support, including a tube through the mouth into the lungs and connected to a breathing machine (ventilator)

Outlook (Prognosis)

Recovery is likely if the person survives the first 24 hours. Complications such as pneumonia, muscle damage from lying on a hard surface for a long period of time, or brain damage from lack of oxygen may result in permanent disability.

Few people actually die from an antihistamine overdose. However, serious heart rhythm disturbances may occur, which can cause death.

Keep all medicines in child-proof bottles and out of reach of children.

Case reports

A 13-month-old male who ingested 20 diphenhydramine (25 mg) tablets presented with seizures and ultimately progressed to status epilepticus and wide-complex tachycardia ¹³. Due to worsening clinical course, hemodialysis was performed with temporal resolution of his symptoms. Hemodialysis may be considered in critically ill diphenhydramine overdoses not responsive to conventional supportive care.

Case report

Diphenhydramine toxicity manifests with signs of anticholinergic toxicity; therapy is generally supportive ¹⁴. In rare cases, patients can also present with a wide complex tachycardia due to sodium channel blockade. Treatment involves sodium bicarbonate. Lidocaine and hypertonic saline are used for arrhythmias refractory to sodium bicarbonate. Although intravenous fat emulsion (IFE) therapy is proposed as an adjunctive therapy due to the lipophilicity of diphenhydramine (octanol/water partition coefficient of 3.3), successful use of intravenous fat emulsion after a confirmed sole ingestion of diphenhydramine is not previously reported. This case study ¹⁴ present the case of a 30-year-old woman presenting with seizures, a wide complex tachycardia, and cardiovascular collapse after an ingestion of diphenhydramine refractory to other therapies with rapid improvement after intravenous fat emulsion administration.

Case report

Overdosage of diphenhydramine may result in the development of anticholinergic symptoms, seizures, and coma ¹⁵. A fatal outcome following a diphenhydramine overdose does not commonly occur. This report describes /an/ overdosage of diphenhydramine (7.5 g) which resulted in the death of a 14-year-old girl. The patient initially developed seizures following by cardiac conduction and hemodynamic compromise resulting in death despite life support measures ¹⁵.

Case report

Overdosage and toxicity (including death) have been reported in children younger than 2 years of age receiving nonprescription (over-the-counter, OTC) preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection ¹. There is limited evidence of efficacy for these preparations in this age group, and appropriate dosages (i.e., approved by the US Food and Drug Administration [FDA]) for the symptomatic treatment of cold and cough have not been established ¹. Therefore, FDA stated that nonprescription cough and cold preparations should not be used in children younger than 2 years of age; the agency continues to assess safety and efficacy of these preparations in older children. Meanwhile, because children 2-3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently have agreed to voluntarily revise the product labeling to state that such preparations should not be used in children younger than 4 years of age. Because FDA does not typically request removal of products with previous labeling from pharmacy shelves during a voluntary label change, some preparations will have the new recommendation (“do not use in children younger than 4 years of age”), while others will have the previous recommendation (“do not use in children younger than 2 years of age”). FDA recommends that parents and caregivers adhere to the dosage instructions and warnings on the product labeling that accompanies the preparation if administering to children and consult with their clinician about any concerns.

Case report

Two cases of diphenhydramine-containing hypnotics overdose, exhibiting delirium and involuntary choreic movement were identified ¹⁶. In case 1, a 32-year-old man ingested 24 tablets of Drewell, each containing 25 mg diphenhydramine, in a suicidal attempt. About four hours after ingestion, he showed generalized convulsion, delirium, and involuntary choreic movements ¹⁶. Intravenous diazepam was ineffective and he was sedated with continuous infusion of propofol. About 15 hours after ingestion and on discontinuing the sedation, he became alert and did not show any neurological abnormality. The blood concentration of diphenhydramine, measured by liquid chromatography/electrospray mass spectrometry, was 1.26 ug/ mL. In case 2, a 24-year-old woman ingested 114 tablets of Drewell and was admitted to a hospital ¹⁶. Her consciousness was impaired and she was treated with intravenous fluids. About four hours after ingestion, she became restless and showed confusion, agitation, and involuntary choreic movements ¹⁶. Sedation with continuous propofol infusion was required. She awoke the next day on discontinuing the sedation, and she did not show any neurological abnormalities. The blood concentration of diphenhydramine was 2.37 ug/mL. It is suggested that physicians should be aware of psychotic-like symptoms and choreic involuntary movement in patients with diphenhydramine-containing hypnotics overdose ¹⁶.

Case report

A 13-month-old infant girl was brought in by the emergency medical service for a witnessed tonic-clonic seizure ¹⁷. Two hours previously, the child had been found with an open bottle of 25-mg diphenhydramine tablets, 24 of which were missing. Midazolam was administered with seizure resolution ¹⁷. Examination revealed 4-mm reactive pupils; nystagmus; warm, dry, flushed skin; and altered mental status. Initial electrocardiograms revealed sinus tachycardia at a rate of 180 beats per minute, a prolonged QRS of 130 milliseconds (from a baseline of 65 milliseconds), and a positive terminal R wave in aVR, which later resolved after sodium bicarbonate treatment. The patient was discharged home the following day with no sequelae ¹⁷.

Case report

A 36-year-old woman with a medical history of hypothyroidism on levothyroxine was brought to the emergency department with active seizures by emergency medical services after what was later determined to be a diphenhydramine overdose ¹⁸. One hour after an argument with her husband he found her lethargic in a locked room. Initial vital signs were: blood pressure, 90/55 mmHg; heart rate, 160 beats/min; respiratory rate 18 breaths/min; room air oxygen saturation, 99%; temperature, 99.8 deg F; rapid point-of-care glucose, 130 mg/dL. The generalized seizures continued for duration of 30 min, despite the intravenous administration of 8 mg of lorazepam. The patient underwent endotracheal intubation and a propofol infusion terminated her seizures. An electrocardiogram after the status was terminated which revealed a wide-complex tachycardia with QRS duration of 127 ms. The QRS narrowed after 200 mEq of intravenous sodium bicarbonate was administrated. The patient was neurologically intact upon extubation on hospital day 2. The serum diphenhydramine concentration drawn on arrival to the ED was 1200 ng/mL (9-120 ng/mL); a tricyclic screen was negative. While seizures and sodium channel blockade are recognized complications of diphenhydramine toxicity, reported cases of status epilepticus from diphenhydramine overdose are rare. Elements of the patient’s presentation were similar to a tricyclic overdose and management required aggressive control of her seizures, sodium bicarbonate therapy, and recognizing that physostigmine was contraindicated due to wide complex tachycardia. Diphenhydramine overdose may cause status epilepticus and wide-complex tachycardia. Management should focus on antidotal therapy with sodium bicarbonate and supportive neurological management with appropriate anticonvulsants and airway protection if clinically indicated ¹⁸.

Case report

Drug- and toxin-induced rhabdomyolysis is a nonspecific clinical syndrome resulting from the release of skeletal muscle cell contents into the plasma and urine. Antihistamine drugs are the active ingredients in a number of over-the-counter preparations and are frequently ingested in suicide attempts. The authors report rhabdomyolysis as a rare adverse effect of diphenhydramine toxicity in a 29-year-old man who ingested an unknown quantity of an over-the-counter sleep preparation in a suicide attempt ¹⁹. The patient had documented toxic concentration of diphenhydramine in his cerebrospinal fluid and no history of seizures, coma, or hypothermia. A high index of suspicion and an evaluation for rhabdomyolysis is warranted in antihistamine toxicity.

Case report

A case of electrocardiographic signature of the Brugada syndrome: a genetic condition that causes disruption of the heart’s normal rhythm in a 39-year-old patient with an overdose of diphenhydramine is reported ²⁰. He was found unconscious and hypotensive. His serum potassium concentration was 8.3 mEq/L and the ECG revealed a coved-type ST-segment elevation in leads V2-V3. These repolarization abnormalities neither normalize with the correction of the hyperkalemia nor with an intravenous infusion of isoproterenol. When he regained consciousness, he was admitted the toxic ingestion of diphenhydramine and progressively the ECG normalized. A negative flecainide test confirmed that the transient ECG abnormalities were the consequence of the drug overdose and ruled out the Brugada syndrome ²⁰.

Case report

Diphenhydramine it can cause paradoxical central nervous system stimulation in children, with effects ranging from excitation to seizures and death ²¹. Reports of fatal intoxications in young children are rare. The authors present five cases of fatal intoxication in infants 6, 8, 9, 12, and 12 weeks old ²¹. Postmortem blood diphenhydramine levels in the cases were 1.6, 1.5, 1.6, 1.1 and 1.1 mg/L, respectively. Anatomic findings in each case were normal. In one case the child’s father admitted giving the infant diphenhydramine in an attempt to induce the infant to sleep; in another case, a daycare provider admitted putting diphenhydramine in a baby bottle ²¹. Two cases remain unsolved; one case remains under investigation. The postmortem drug levels in these cases are lower than seen in adult fatalities ²¹.

Case report

Diphenhydramine toxicity (e.g., dilated pupils, facial flushing, hallucinations, ataxic gait, urinary retention) has been reported in pediatric patients (19 months to 9 years of age) following topical application of diphenhydramine to large areas of the body (often areas with broken skin) or following concomitant use of topical and oral preparations containing the drug for self-medication in the symptomatic management of pain and pruritus associated with varicella (chickenpox), poison ivy, or sunburn ¹. Manifestations typically resolved within 48 hours following discontinuance of the drug, and no deaths have been reported following topical use of diphenhydramine alone.

1. American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 10
2. Troy, D.B. (Ed); Remmington The Science and Practice of Pharmacy. 21 st Edition. Lippincott Williams & Williams, Philadelphia, PA 2005, p. 1545
3. Brunton, L. Chabner, B, Knollman, B. Goodman and Gillman’s The Pharmaceutical Basis of Therapeutics, Twelth Edition, McGraw Hill Medical, New York, NY. 2011, p. 923
4. Benzodiazepines. https://mothertobaby.org/fact-sheets/benzodiazepines-pregnancy/pdf/
5. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. https://www.ncbi.nlm.nih.gov/pubmed/8498418
6. Messinis IE, Souvatzoglou A, Fais N et al. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8:143-6. https://www.ncbi.nlm.nih.gov/pubmed/3928731
7. USP Convention. USPDI – Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 327
8. USP Convention. USPDI – Drug Information for the Health Care Professional. 15 th ed. Volume 1. Rockville, MD: United States Pharmacopeial Convention, Inc., 1995. (Plus updates.), p. 306
9. OLSON, K.R. (Ed). Poisoning and Drug Overdose, Sixth Edition. McGraw-Hill, New York, NY 2012, p. 478
10. Krenzelok EP et al; Ann Emerg Med 11 (4): 212-3; 1982 https://www.ncbi.nlm.nih.gov/pubmed/7073039
11. Aronson JK. Anticholinergic drugs. In: Aronson JK, ed. Meyler’s Side Effects of Drugs. 16th ed. Waltham, MA: Elsevier; 2016:534-539.
12. Monte AA, Hoppe JA. Anticholinergics. In: Walls RM, Hockberger RS, Gausche-Hill M, eds. Rosen’s Emergency Medicine: Concepts and Clinical Practice. 9th ed. Philadelphia, PA: Elsevier; 2018:chap 145.
13. McKeown NJ, West PL, Hendrickson RG, Horowitz BZ. Survival after Diphenhydramine Ingestion with Hemodialysis in a Toddler. Journal of Medical Toxicology. 2011;7(2):147-150. doi:10.1007/s13181-010-0116-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3724430/
14. Life-threatening diphenhydramine toxicity presenting with seizures and a wide complex tachycardia improved with intravenous fat emulsion. Am J Ther. 2014 Nov-Dec;21(6):542-4. doi: 10.1097/MJT.0b013e318281191b. https://www.ncbi.nlm.nih.gov/pubmed/24096706
15. Massive diphenhydramine overdose resulting in death. Ann Emerg Med. 1982 Apr;11(4):212-3. https://www.annemergmed.com/article/S0196-0644(82)80501-5/pdf
16. [Diphenhydramine poisoning presented with psychotic-like symptoms and choreic involuntary movement: report of two cases]. Chudoku Kenkyu. 2007 Apr;20(2):125-9. https://www.ncbi.nlm.nih.gov/pubmed/17533963
17. Wide complex tachycardia in a pediatric diphenhydramine overdose treated with sodium bicarbonate. Pediatr Emerg Care. 2011 Dec;27(12):1175-7. doi: 10.1097/PEC.0b013e31823b0e47 https://www.ncbi.nlm.nih.gov/pubmed/22158278
18. JANG DH, MANINI AF, TRUEGER NS, et al. Status epilepticus and wide-complex tachycardia secondary to diphenhydramine overdose. Clinical toxicology (Philadelphia, Pa). 2010;48(9):945-948. doi:10.3109/15563650.2010.527850. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4091778/
19. Emadian SM et al; Am J Emerg Med 14 (6): 574-6; 1996 https://www.ncbi.nlm.nih.gov/pubmed/8857809
20. Lopez-Barbeito B et al; Pacing Clin Electrophysiol 28 (7): 730-2;2005 https://www.ncbi.nlm.nih.gov/pubmed/16008813
21. Baker AM et al; J Forensic Sci 48 (2): 425-8;2003 https://www.ncbi.nlm.nih.gov/pubmed/12665005

What is alka seltzer

Alka Seltzer is a medicine that contains the following active ingredients: Anhydrous Citric Acid 1000mg (antacid), Aspirin 325mg (an analgesic – nonsteroidal anti-inflammatory drug) and Sodium Bicarbonate 1916mg (baking soda – antacid). Alka-Seltzer is used for the relief of heartburn, upset stomach, acid indigestion with headache and body aches.

In Alka Seltzer Extra Strength the active ingredients are: Anhydrous Citric Acid 1000mg (antacid), Aspirin 500mg (an analgesic – nonsteroidal anti-inflammatory drug) and Sodium Bicarbonate 1985mg (baking soda – antacid).

In Alka Seltzer Extra Strength Heartburn Relief Chews the active ingredient is: Calcium Carbonate 750mg (antacid).

Other information:

• each Alka Seltzer tablet contains: sodium 567 mg
• store at room temperature. Avoid excessive heat.
• Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients:

• none

There is another type of Alka Seltzer medicine called “Alka Seltzer – Heartburn” that contains only Anhydrous citric acid 1000 mg (antacid) and Sodium bicarbonate (heat-treated) 1940 mg (antacid) without the added Aspirin. The directions of use and dosage is the same as the standard Alka Seltzer, except it contains phenylalanine 5.6 mg per tablet which is contraindicated for people with phenylketonuria.

Alka seltzer uses

Alka Seltzer main uses are for:

• heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
• upset stomach with headache from overindulgence in food or drink
• headache, body aches, and pain alone

How often can you take alka seltzer

Directions of use of standard Alka Seltzer:

Fully dissolve 2 tablets in 4 ounces of water before taking

• Children under 12 years: Consult a doctor for advice
• Adults and children 12 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours
• Adults 60 years and over: take 2 tablets every 4, or as directed by a doctor. Do not exceed 4 tablets in 24 hours

For Alka Seltzer Extra Strength:

Fully dissolve 2 tablets in 4 ounces of water before taking

• Children under 12 years: Consult a doctor for advice
• Adults and children 12 years and over: take 2 tablets every 6 hours, or as directed by a doctor. Do not exceed 7 tablets in 24 hours
• Adults 60 years and over: take 2 tablets every 6 hours, or as directed by a doctor. Do not exceed 3 tablets in 24 hours.

Alka Seltzer Extra Strength Heartburn Relief Chews

• Children under 12 years: Consult a doctor for advice
• Adults and children 12 years and over: fully chew then swallow 1 or 2 chewable tablets as symptoms occur, or as directed by a doctor. Do not exceed exceed 5 chewable tablets in 24 hours
• Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician
• Each chewable tablet contains calcium 300mg.
• Constipation may occur.

How does alka seltzer work

When too much acid builds up in your stomach, it can feel upset. Alka-Seltzer is an antacid or “buffer” which neutralizes stomach acid keeping your stomach from being too acidic.

Alka Seltzer Side Effects

Do NOT use

• if you are allergic to aspirin or any other pain reliever/fever reducer
• if you have ever had an allergic reaction to this product or any of its ingredients

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.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

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

Stomach bleeding warning

This product contains Aspirin which is a 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

Ask a doctor before use if:

• 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 a sodium-restricted diet

Ask a doctor or pharmacist before use if you are:

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.
• taking a prescription drug for diabetes, gout, or arthritis.

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
• symptoms get worse or last more than 10 days
• redness or swelling is present
• ringing in the ears or a loss of hearing occurs
• new symptoms occur

Alka seltzer pregnant

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

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.

Keep out of reach of children.

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

What is motrin

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

Motrin works on one of the chemical pathways for pain. It 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.

Motrin PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine – that reduces the effects of natural chemical histamine in your body. Motrin PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains. Motrin PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.

What is Motrin used for?

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

Motrin 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.
• Motrin 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 Motrin provides only temporary relief – it won’t cure your condition.

Motrin PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine – that reduces the effects of natural chemical histamine in your body.

Motrin PM is a combination medicine used to treat occasional insomnia associated with minor aches and pains.

Motrin PM is not for use in treating sleeplessness without pain, or sleep problems that occur often.

• Diphenhydramine 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.
• Diphenhydramine is used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.
• Diphenhydramine is also used to treat motion sickness, to induce sleep, and to treat certain symptoms of Parkinson’s disease.

Important information on Diphenhydramine (Motrin PM)

When taking diphenhydramine, use caution driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

Diphenhydramine side effects

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

Stop using diphenhydramine (Motrin PM) and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest;
• painful or difficult urination;
• little or no urinating;
• confusion, feeling like you might pass out; or
• tightness in your neck or jaw, uncontrollable movements of your tongue.

Common diphenhydramine side effects may include:

• dizziness, drowsiness, loss of coordination;
• dry mouth, nose, or throat;
• constipation, upset stomach;
• dry eyes, blurred vision; or
• day-time drowsiness or “hangover” feeling after night-time use.

Motrin vs Ibuprofen

Motrin IB contains ibuprofen – an ingredient that provides powerful pain relief.

Motrin PM combines both ibuprofen (NSAID) with an antihistamine – Diphenhydramine, which provides powerful pain relief and helps you fall asleep and stay asleep.

How long does it take for Motrin to work?

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

For some types of long-term pain, you’ll need to take Motrin (ibuprofen) regularly for up to 3 weeks for it to work properly.

If you’re applying ibuprofen to your skin, it should start to work within 1 to 2 days.

Taking Motrin with other painkillers

It’s safe to take Motrin (ibuprofen) with acetaminophen or codeine.

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

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

Alternatives to Motrin

For treating fever, an alternative to Motrin (ibuprofen) is acetaminophen (Tylenol).

For pain or inflammation-related swelling, ask your doctor or pharmacist for an alternative if Motrin (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 or Motrin (ibuprofen) in the same tablet.

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

Is Motrin better than acetaminophen or aspirin?

Motrin (ibuprofen), acetaminophen (paracetamol) and aspirin are all effective painkillers.

Motrin (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. It may be better than Motrin (ibuprofen) for headaches, toothache, sprains, stomach ache, and nerve pain like sciatica.

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

How long will I take Motrin tablets for?

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

You may need to take Motrin (ibuprofen) for longer if you have a long-term health problem, such as rheumatoid arthritis.

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

Can I take Motrin for a long time?

It’s safe to take Motrin (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 Motrin (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 Motrin cause stomach ulcers?

Motrin (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 Motrin (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 Motrin?

It’s usually safe to drink alcohol while taking Motrin (ibuprofen). But if you’re taking Motrin (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 Motrin (ibuprofen).

It’s best to take Motrin (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 Motrin doesn’t work?

If Motrin (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)

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

Motrin (ibuprofen) doesn’t work for certain types of pain – for example, nerve pain like sciatica. Your doctor will have to prescribe a different medicine if your pain is related to your nerves.

Will Motrin affect my fertility?

Taking Motrin (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 Motrin (ibuprofen).

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

Will Motrin affect my contraception?

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

Pregnancy and breastfeeding

Motrin (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 Motrin (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 ¹.

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 ². 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 ². 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 ². 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 ².

Motrin (ibuprofen) and breastfeeding

Motrin (ibuprofen) is safe to take by mouth if you are breastfeeding.

Two early studies attempted measurement of ibuprofen in milk ³, ⁴. 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) ³, ⁴.

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 ⁵ 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 ⁶.

How should Motrin be used?

Prescription Motrin (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 Motrin (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 Motrin (ibuprofen) every 4 to 6 hours as needed for pain or fever. Children and infants may usually be given nonprescription Motrin (ibuprofen) every 6 to 8 hours as needed for pain or fever, but should not be given more than 4 doses in 24 hours. Motrin (ibuprofen) may be taken with food or milk to prevent stomach upset. If you are taking Motrin (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 Motrin (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.

Motrin (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 Motrin (ibuprofen), you should be careful not to take any nonprescription medications that also contain Motrin (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 Motrin (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 Motrin (ibuprofen) or a combination product that contains Motrin (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 Motrin (ibuprofen) products that are made for adults to children.

Before you give an Motrin (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 Motrin (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 Motrin (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 Motrin (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 Motrin (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.

Other uses for Motrin

Motrin (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.

Before taking Motrin

• tell your doctor and pharmacist if you are allergic to Motrin (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 Motrin (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 Motrin (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 Motrin (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 Motrin (ibuprofen), call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Motrin (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 Motrin (ibuprofen). Some types of nonprescription Motrin (ibuprofen) may be sweetened with aspartame, a source of phenylalanine.

Motrin dosage chart

A few reminders:

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

Motrin IB Caplets Directions of use

• do not take more than directed
• the smallest effective dose should be used

Uses:

• temporarily relieves minor aches and pains due to:
• headache
• muscular aches
• minor pain of arthritis
• toothache
• backache
• the common cold
• menstrual cramps
• temporarily reduces fever

Table 1. Motrin IB Caplets

Motrin IB Caplets Active ingredients (in each caplet):

1. Ibuprofen 200 mg (NSAID)/Purpose: Pain reliever and fever reducer

Inactive ingredients:

• carnauba wax, colloidal silicon dioxide, FD&C yellow no.6, hypromellose, iron oxide, magnesium stearate, modified starch, polydextrose, polyethylene glycol, pregelatinized starch, propylene glycol, shellac, stearic acid, titanium dioxide

or

• colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, iron oxides, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide.

Other instructions:

• read all warnings and directions before use. Keep carton.
• store between 20-25°C (68-77°F)

Motrin IB Liquid Gels Directions of use

• do not take more than directed
• the smallest effective dose should be used

Uses:

• temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • minor pain of arthritis
  • toothache
  • backache
  • the common cold
  • menstrual cramps
• temporarily reduces fever

Table 2. Motrin IB Liquid Gels

Motrin IB Liquid Gels Active ingredients (in each caplet):

1. Active ingredient (in each capsule): Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID) (present as the free acid and potassium salt)/Pain reliever and fever reducer

Inactive ingredients:

• gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan and sorbitol

Other instructions:

• each capsule contains: potassium 20 mg
• store between 20-25ºC (68-77ºF)
• avoid excessive heat above 40ºC (104ºF). Protect from light.

Motrin PM Caplets Directions of use

• do not take more than directed
• adults and children 12 years and over: take 2 caplets at bedtime
• do not take more than 2 caplets in 24 hours

Uses:

• for relief of occasional sleeplessness when associated with minor aches and pains
• helps you fall asleep and stay asleep

Table 3. Motrin PM Caplets

MOTRIN® PM Caplets Active ingredients (in each caplet):

1. Diphenhydramine citrate 38 mg/Purpose: Nighttime sleep-aid
2. Ibuprofen 200 mg (NSAID)/Purpose: Pain reliever and fever reducer

Inactive ingredients:

• colloidal silicon dioxide, croscarmellose sodium, glyceryl behenate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Other instructions:

• 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)

Children’s Motrin Directions of use

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• mL=milliliter
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• use only enclosed dosing cup. Do not use any other dosing device.
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day
• replace original bottle cap to maintain child resistance

Uses:

• Temporarily relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache
• Reduces fever

Table 4. Children’s Motrin

*or as directed by a doctor.

Children’s Motrin Active ingredients:

• Active ingredient (in each 5 mL): Ibuprofen 100 mg (NSAID)/ Purpose: Pain reliever/fever reducer

Inactive ingredients:

• Bubble Gum: acesulfame potassium, anhydrous citric acid, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
• Grape: acesulfame potassium, anhydrous citric acid, D&C red no. 33, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
• Berry: acesulfame potassium, anhydrous citric acid, D&C yellow no. 10, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
• Dye-Free Berry: acesulfame potassium, anhydrous citric acid, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum

Other instructions:

• each 5 mL contains: sodium 2 mg
• store between 20-25°C (68-77°F)

Infants’ Motrin Directions of use

• this product does not contain directions or complete warnings for adult use
• do not give more than directed
• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise use age.
• mL=milliliter
• measure with the dosing device provided. Do not use with any other device.
• dispense liquid slowly into the child’s mouth, toward the inner cheek
• if needed, repeat dose every 6-8 hours
• do not use more than 4 times a day

Uses:

• Temporarily relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
• Reduces fever

Table 5. Infants’ Motrin Dosage

Infants’ Motrin Active ingredients:

• Active ingredient (in each 1.25 mL): Ibuprofen 50mg (NSAID)/ Purpose: Pain reliever/fever reducer

Inactive ingredients:

• Berry: anhydrous citric acid, caramel, FD&C red no. 40, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum
• Dye-Free Berry: anhydrous citric acid, caramel, flavors, glycerin, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sorbitol solution, sucrose, xanthan gum

Other instructions:

• store between 20-25°C (68-77°F)

Motrin side effects

Common side effects

The common side effects of Motrin (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 Motrin (ibuprofen) when you are over 65, or have an ulcer, so discuss this with your doctor. Motrin (ibuprofen), like all NSAIDs, can also make heart disease worse – talk to your doctor before taking Motrin (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

Motrin (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 Motrin (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 Motrin (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 Motrin (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.

Motrin IB Side Effects

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

Motrin IB 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 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

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

Ask a doctor before use if:

• you have problems or serious side effects from taking pain relievers or fever reducers
• the 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, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

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

When using this product:

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

• 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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• 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

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.

Motrin IB Liquid Gels Side Effects

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 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

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

Ask a doctor before use if:

• you have problems or serious side effects from taking pain relievers or fever reducers
• the 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, kidney disease, asthma, or had a stroke
• you are taking a diuretic

Ask a doctor or pharmacist before use if you are:

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

When using this product

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

• 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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• 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

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.

Children’s Motrin Side Effects

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 NSAID, which may cause severe stomach bleeding. The chance is higher if your child:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• takes more or for a longer time than directed

Heart attack and stroke warning

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.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do NOT use

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

Ask a doctor before use if:

• stomach bleeding warning applies to your child
• child has a history of stomach problems, such as heartburn
• child has problems or serious side effects from taking pain relievers or fever reducers
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
• child has asthma
• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is:

• under a doctor’s care for any serious condition
• taking any other drug

When using this product:

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

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

Infants’s Motrin Side Effects

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 NSAID, which may cause severe stomach bleeding. The chance is higher if your child:

• has had stomach ulcers or bleeding problems
• takes a blood thinning (anticoagulant) or steroid drug
• takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• takes more or for a longer time than directed

Heart attack and stroke warning

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.

Sore throat warning

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Do NOT use

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

Ask a doctor before use if:

• stomach bleeding warning applies to your child
• child has a history of stomach problems, such as heartburn
• child has problems or serious side effects from taking pain relievers or fever reducers
• child has not been drinking fluids
• child has lost a lot of fluid due to vomiting or diarrhea
• child has high blood pressure, heart disease, liver cirrhosis, kidney disease, or had a stroke
• child has asthma
• child is taking a diuretic

Ask a doctor or pharmacist before use if the child is:

• under a doctor’s care for any serious condition
• taking any other drug

When using this product:

• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

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

Motrin PM Side Effects

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 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

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 have ever had an allergic reaction to any other pain reliever/fever reducer
• unless you have time for a full night’s sleep
• in children under 12 years of age
• right before or after heart surgery
• with any other product containing Diphenhydramine, even one used on skin
• if you have sleeplessness without pain

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
• you have a breathing problem such as emphysema or chronic bronchitis
• you have glaucoma
• you have trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

• taking sedatives or tranquilizers, or any other sleep-aid
• under a doctor’s care for any continuing medical illness
• taking any other antihistamines
• taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
• taking any other drug

When using this product:

• drowsiness will occur
• avoid alcoholic drinks
• do not drive a motor vehicle or operate machinery
• take with food or milk if stomach upset occurs

Stop use and ask a doctor if:

• 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
• you have symptoms of heart problems or stroke:
  • chest pain
  • trouble breathing
  • weakness in one part or side of body
  • slurred speech
  • leg swelling
• pain gets worse or lasts more than 10 days
• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
• redness or swelling is present in the painful area
• any new symptoms appear

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.

Diphenhydramine and ibuprofen may pass into breast milk and may harm a nursing baby. Antihistamines may also slow breast milk production. Do not use this medicine without a doctor’s advice if you are breast-feeding a baby.

This medicine is not approved for use by anyone younger than 12 years old. Always ask a doctor before giving an antihistamine to a child. Death can occur from the misuse of antihistamines in very young children.

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 ⁷. 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 ⁷.

Fatal autoimmune hemolytic anemai occurred coincident with oral administration of ibuprofen 400 mg 3 times per day in 49 yr old male ⁸.

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 ⁹.

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 ¹⁰.

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 ¹¹.

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 ¹². 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 ¹². 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 ¹².

In a series of 293 patients treated during a five year period no visual symptoms were detected that were thought attributable to the drug ¹² 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 ¹².

Chemically induced renal dysfunction caused by ibuprofen is dose/duration related ¹³. 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 ¹⁴. This study ¹⁴ 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 ¹⁴ 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 ¹⁴.

Motrin overdose

Can you overdose on Motrin? Yes

In case of Motrin 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 Motrin 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. Stockton, D.L. and A.S. Paller. J Am Acad Dermatol 23 (1):87-103; 1990
2. J Toxicol Clin Toxicol 2003;41(4):551-2
3. 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
4. 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
5. Walter K, Dilger C. Ibuprofen in human milk. Br J Clin Pharmacol. 1997;44:211-2
6. 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
7. 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
8. GUIDRY JB ET AL; JAMA 242 (JUL 6): 68; 1979 https://jamanetwork.com/journals/jama/article-abstract/365628
9. WARRINGTON SJ ET AL; RHEUMATOLOGY 7 (NEW TRENDS OSTEOARTHRITIS): 107;1982
10. COURT H ET AL; HUM TOXICOL 2 (2): 381; 1983 https://www.ncbi.nlm.nih.gov/pubmed/6862484
11. Lortholary A et al; Rev Med Interne 11 (3): 243-4; 1990 https://www.ncbi.nlm.nih.gov/pubmed/2096424
12. Grant, W.M. Toxicology of the Eye. 3rd ed. Springfield, IL: Charles C. Thomas Publisher, 1986., p. 506
13. 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
14. Head JE et al; Bone 29 (5): 437-41; 2001 https://www.ncbi.nlm.nih.gov/pubmed/11704495

What is pedialyte

Pedialyte is an oral rehydration solution that is used to add back fluid after fluid loss or to help prevent fluid and electrolyte problems. Pedialyte is a medical-grade hydration solution specially formulated with the optimal balance of sugar and electrolytes needed to help replenish vital fluids, minerals, and nutrients, which, when lost, can lead to dehydration ¹. Pedialyte (oral rehydration solution) main purpose is to rehydrate your body from all sorts of dehydration causes. Both adults and kids can use Pedialyte for rehydration. Rehydrating with Pedialyte helps everyone with dehydration due to diarrhea and vomiting—adults and kids to feel better fast. For example, most people will experience diarrhea — loose watery stools — at some time in their life. Most people do not need any specific treatment for infectious diarrhea as it usually improves on its own in a couple of days. However, it is important to drink plenty of liquids to keep well hydrated. This is especially important for children and babies. Dehydration happens when you haven’t got enough fluids in your body. Dehydration means your body loses more fluids than you take in. If it isn’t treated it can get worse and become a serious problem. If severe, dehydration can cause serious problems.

Children under 5s should get plenty of fluids to avoid dehydration. It’s quite common for young children to become dehydrated. It can be serious if it’s not dealt with quickly. The body needs to have enough fluid to be able to function at its best. Children are at risk of dehydration, especially in hot weather and when they are exercising. By the time they feel thirsty, they are probably already dehydrated – so it’s up to parents and carers to make sure they are drinking enough.

What does your child need to stay well hydrated?

• Water is the best choice for children.
• Avoid sports drinks, fruit juices, soft drinks and flavoured mineral waters since they all contain sugar, which can lead to tooth decay.

The recommended daily intake of water for children is:

• 5 to 8 years old: 5 glasses (1 liter)
• 9 to 12 years old: 7 glasses (1.5 liters)
• 13 years old and over: 8 to 10 glasses (2 liters).

Children need even more water when they are exercising. Your child should drink before, during and after physical activity – even if they aren’t thirsty.

Tips to help your child stay hydrated

• make sure they always pack a water bottle
• choose water rather than sugary drinks
• remind them to drink before a sports game
• encourage them to have a few mouthfuls of water during any breaks in the game
• make sure they have a big drink afterwards to make up for any sweat they have lost.

Mild dehydration can be treated by giving your child more to drink. But serious dehydration – for example, if they are unwell – can be very serious. It’s important to know what to look out for.

How does pedialyte work?

Oral rehydration solutions like Pedialyte are specifically designed fluids that contain an appropriate amount of sodium, glucose and other electrolytes and are of the appropriate osmolality, to maximize water absorption from the gut. They use the principle of glucose-facilitated sodium transport whereby glucose enhances sodium and secondarily water transport across the mucosa of the upper intestine ². The sodium and glucose concentrations and the osmolality are of vital importance.

The World Health Organisation (WHO) recommends an oral rehydration solution that has a sodium concentration of 60-90mmol/L ³.

The total substance concentration (including that contributed by glucose) should be within the range of 200-310 mmol/l.

Table 1. World Health Organisation (WHO) recommends an oral rehydration solution

New formula oral rehydration salts

A new formula for oral rehydration salts (ORS), has been released by the World Health Organization ³. The new formula oral rehydration salts (ORS), a sodium and glucose solution is widely used to treat children with acute diarrhea.

The new improved formula is the result of extensive research sponsored by WHO’s Department of Child and Adolescent Health and Development and supported by the United States Agency for International Development (USAID). The latest study was conducted in five developing countries among children from one month to two years old with acute diarrhoea and dehydration.

The study’s findings suggest that using the low-sodium, low-glucose ORS formulation reduces the need for intravenous fluids by 33 percent. The effect of this reduction could result in fewer children requiring hospitalization, fewer secondary infections, a diminished need to handle blood with its potentially dangerous consequences, and lower health care costs.

For the past 20 years, numerous studies have been undertaken to develop an “improved” oral rehydration solution. The goal was a product that would be at least as safe and effective as standard oral rehydration solution for preventing or treating dehydration from all types of diarrhoea but which, in addition, would reduce stool output or have other important clinical benefits. One approach has consisted in reducing the osmolarity of oral rehydration salts (ORS) solution to avoid possible adverse effects of hypertonicity on net fluid absorption. This was done by reducing the solution’s glucose and salt (NaCl) concentrations.

Studies to evaluate this approach were reviewed at a consultative technical meeting held in New York and technical recommendations were made to WHO and UNICEF on the efficacy and safety of reduced osmolarity oral rehydration salts (ORS) in children with acute non-cholera diarrhoea, and in adults and children with cholera.

These studies showed that the efficacy of oral rehydration salts (ORS) solution for treatment of children with acute non-cholera diarrhoea is improved by reducing its sodium concentration to 75 mEq/l, its glucose concentration to 75 mmol/l, and its total osmolarity to 245 mOsm/l. The need for unscheduled supplemental IV therapy in children given this solution was reduced by 33%. In a combined analysis of this study and studies with other reduced osmolar-ity Oral rehydration solution solutions (osmolarity 210-268 mOsm/l, sodium 50-75 mEq/l) stool output was also reduced by about 20% and the incidence of vomiting by about 30%. The 245 mOsm/l solution also appeared to be as safe and at least as effective as standard oral rehydration salts (ORS) for use in children with cholera.

Table 2. World Health Organisation (WHO) New formula oral rehydration salts

Note: ORS = oral rehydration salts

In developed countries with non-cholera diarrhoea, it is generally thought that 90mmol/L is a little high, as non-cholera gastroenteritis does not result in the same sodium losses that are seen in cholera. Many different oral rehydration solutions with varying sodium concentrations have been developed. It has been shown ⁴ that water absorption across the lumen of the human intestine is maximal using solutions with a sodium concentration of 60mmol/L (such as Gastrolyte) and this is the concentration recommended by the European Society of Paediatric Gastroenterology and Nutrition ⁵. However some children who are not particularly dehydrated will refuse to drink such an oral rehydration solution because of its salty taste. Oral rehydration solutions with slightly less sodium such as Hydralyte may be more palatable, particularly as this comes in an iceblock form. Oral rehydration solutions with similar compositions to Hydralyte are safe and effective. These hypo-osmolar solutions (such as Gastrolyte and Hydralyte) are more effective at promoting water absorption than isotonic or hypertonic solutions ⁶.

The composition of various oral rehydration solutions and other fluids is shown in Tables 3 and 4. Fruit juices and soft drinks are inappropriate because of the minimal sodium content and the excessive glucose content and hence excessive osmolality, which will worsen diarrhea. Although diluting juices and soft drinks reduces glucose concentration, the fluid has insufficient sodium to act as a rehydration fluid. Sports drinks have varying sodium and carbohydrate levels, and are considered inappropriate as rehydration solutions.

Table 3. Composition of Oral Rehydration Solutions

Table 4. Composition of Oral Fluids

How to make Oral Rehydration Solution at home

To prevent too much liquid being lost from the child’s body, an effective oral rehydration solution can be made using ingredients found in almost every household. One of these drinks should be given to the child every time a watery stool is passed.

Here’s how you can make your own One (1) Liter Oral Rehydration Solution [ORS] using Salt, Sugar and Water at Home

Mix an oral rehydration solution using one of the following recipes:

Ingredients:

• Half (1/2) level teaspoon of Salt
• Six (6) level teaspoons of Sugar
• One (1) Litre of clean drinking or boiled water and then cooled

Make 5 cupfuls (each cup about 200 ml.)

Preparation Method:

• Stir the mixture till the salt and sugar dissolve.

The following traditional remedies make highly effective oral rehydration solutions and are suitable drinks to prevent a child from losing too much liquid during diarrhoea:

• Breastmilk
• Gruels (diluted mixtures of cooked cereals and water)
• Carrot Soup
• Rice water – Congee

A very suitable and effective simple solution for rehydrating a child can also be made by using salt and sugar, if these ingredients are available.

If possible, add 1/2 cup orange juice or some mashed banana to improve the taste and provide some potassium.

Molasses and other forms of raw sugar can be used instead of white sugar, and these contain more potassium than white sugar.

If none of these drinks is available, other alternatives are:

• Fresh fruit juice
• Weak tea
• Green coconut water

If nothing else is available, give water from the cleanest possible source – (if possible brought to the boil and then cooled).

Method of giving oral fluids

It is important to give small amounts of fluid frequently, for example 0.5mL per kg body weight every five minutes ². The fluid can be measured in a syringe and given to the child either by syringe, teaspoon or cup. The child is far more likely to tolerate these small amounts of fluid than if he/she drinks a large amount at once. Obviously if the child tolerates this fluid the parent can gradually increase the volume and decrease the frequency of the fluid offered.

Example of how much fluid to give to your child by age and body weight (approximates only):

• For infants less than 6 months old – See your doctor.
• For 6-23 months give 40 to 60 mL each hour.
• For 2-5 years give 60 to 100 mL each hour.
• For 6-10 years give 100 to 120 mL each hour.
• For 11-16 years give 120 to 160 mL each hour.
• For a 6 kg infant offer: 30mL every hour or 60mL every 2 hours.
• For a 12 kg toddler offer; 60mL every hour or 120mL every 2 hours.

IF YOU HAVE ANY CONCERNS ABOUT YOUR CHILD’S PROGRESS, CONTACT YOUR DOCTOR OR LOCAL HOSPITAL IMMEDIATELY!

Consult your doctor or local hospital, as soon as possible, if you have any concerns about your child’s progress – especially if:

• your child is less than six months old
• your child has other health problems
• you are unable to get your child to take the right amount of fluids (see the table over the page)
• your child keeps vomiting
• your child is very tired or drowsy
• there is blood or mucus in your child’s poo
• there is green vomit
• your child has ongoing tummy pain
• your child has high fevers
• if your child has unexpected symptoms(eg: pain when passing urine, headache etc)
• or if your child does not seem to be getting better and/or you are worried for any other reason.

Medicines to stop vomiting are occasionally used for children with persistent vomiting and dehydration. Medicines to stop diarrhea are not recommended and are usually not helpful as they can cause other problems in children.

If your child tolerates the fluid, gradually increase the amount and decrease the frequency of the fluid offered. It is important to start offering easily digested foods as soon as the vomiting stops and no later than after 24 hours EVEN if the poos are still loose.

Children who are not dehydrated should continue to be fed an age appropriate diet. Children who require rehydration should recommence age appropriate diets as soon as vomiting settles. This should be within the first 12-24 hours. Formula fed infants should recommence full strength formula.

It is important to note that small, frequent amounts of fluid will hopefully minimize the vomiting, but will not reduce the diarrhea. The aim is for the fluid input to exceed the output by enough to rehydrate and then maintain hydration. Occasional vomiting alone should not be considered as failure of oral rehydration therapy.

What to do for a breastfed infant

• Continue breast feeding on demand or at least every 2 hours.
• In between breast feeds, water or oral rehydration solution may be offered.
• Do not give solids if your child is vomiting.

When the vomiting has stopped or after 24 hours:

• Continue 2nd-3rd hourly feeds or on demand.
• In between breast feeds, oral rehydration solution or water may be offered.
• If your baby is on solids introduce simple foods such as rice cereal, potato or pumpkin – even if the poos are still loose.

Parents can use the Parent Oral Rehydration Documentation Form below to record the fluid given and any vomits, diarrhea or urine passed.

Table 5. Parent Oral Rehydration Documentation Form

What to do for the bottle fed infant or older child

While your infant or child is still vomiting:

• Replace formula or usual drinks with oral rehydration fluid (from chemist) or suitable fluids.
• Aim to be back to usual strength formula/diet within 24 hours. If not, seek medical advice.
• Start usual formula or milk. Do not dilute.
• Continue giving feeds or drinks every 2-3 hours or more frequently if demanded.
• Offer age appropriate foods at meal times even if the poos are still loose.
• Occasionally children will develop lactose intolerance and the loose poos will continue. If that occurs, a doctor may advise that he/she will need lactose free milk for approximately 1 month.

Hydration tips for baby and children

Severe vomiting and diarrhea (runny poos) can quickly lead to dehydration in infants and young children. Seek medical attention promptly, if you are concerned. Frequent vomiting and runny poos means your child may be losing a lot of fluid from their body. Lost fluid must be replaced – initially with SUITABLE FLUIDS or BREAST MILK.

DO

• carry on breastfeeding or using formula, try to give small amounts more often than usual
• for babies on formula or solid foods – give them small sips of extra water
• give small children their usual diet
• give regular small sips of rehydration solution to replace lost fluids, salts and sugars – ask your pharmacist to recommend one

DON’T

• make baby formula weaker
• give young children fruit juice or fizzy drinks, it makes things like diarrhea or vomiting worse

Pedialyte for diarrhea

If you’re being sick or have diarrhea and are losing too much fluid you need to put back the sugar, salts and minerals that your body has lost.

Your pharmacist can recommend oral rehydration solution sachets like pedialyte. These are powders that you mix with water and then drink. Ask your pharmacist which ones are right for you or your child.

Oral Rehydration Solutions include Gastrolyte, Hydralyte, Pedialyte and Repalyte (available from chemist) are specially formulated to replace lost fluid. These should be mixed exactly to the manufacturer’s directions. It is very important to comply with the expiry dates of the rehydration solutions once they have been opened or made up. Oral rehydration solutions are specially designed to replace sugars and salts lost during an episode of gastroenteritis. It is better to give these over other clear fluids if it is available. Clear fluids such as juice, cordial or soft drink may be used with caution if an oral rehydration fluid is not available. However they must be diluted otherwise they may make the diarrhea worse.

Other suitable fluids include:

• Diluted cordial (one part cordial concentrate to 20 parts boiled then cooled water). For example, 5 mL (1 teaspoon) plus 100mL water.
• Diluted soft drink or juice (one part juice or soft drink to 5 parts boiled then cooled water). For example, 20 mL (1 tablespoon) plus 80mL water.

Ideally these drinks (preferably those that have been boiled) should contain:

• starches and/or sugars as a source of glucose and energy,
• some sodium and
• preferably some potassium.

What causes dehydration

Dehydration is when someone loses more fluids than they take in. When someone becomes dehydrated, it means the amount of water in their body has dropped below the level needed for normal body function. In hot weather it can be very easy for active children to become dehydrated. Some may even suffer heat exhaustion or even heat stroke. A child is more likely to be affected if they are involved in at least an hour of high intensity physical activity on a hot day. Some examples of high intensity activity include team sports (for example soccer, football or netball), swimming training, running or tennis.

Most children do not stop to drink as much as adults do. They may only stop to drink when they are very thirsty. By this time, children can already be mildly dehydrated.

People can get dehydrated:

• after strenuous exercise, especially in hot weather due to sweating
• after severe vomiting or diarrhea
• with a fever – a high temperature of 100.4 °F (38 °C) or more
• after drinking too much alcohol
• while taking certain medicines such as diuretics
• as a complication of diabetes
• if they don’t drink enough water
• been in the sun too long (heatstroke)

Anyone may become dehydrated, but babies, young children, older adults and people with long-term illnesses are at most risk.

You are dehydrated if your body doesn’t have enough water to keep it working properly. It can happen when your body loses too much fluid, such as from excessive sweating, vomiting or diarrhea.

Dehydration signs and symptoms

If you have mild to moderate dehydration, you might:

• be thirsty
• have a dry mouth, lips, tongue and eyes
• have a headache
• have nausea
• have dark urine, and not so much of it
• feeling dizzy or light-headed, particularly when standing up
• peeing little and less than 4 times a day

If you have severe dehydration, you might:

• be extremely thirsty
• have a very dry mouth
• eyes are dark and sunken
• be breathing fast
• have a fast heart rate and a low blood pressure
• have a fever
• have little or no urine
• be irritable, drowsy or confused

Babies who are severely dehydrated have a sunken fontanel, the soft spot on top of a baby’s head.

Severe dehydration is a serious problem, especially in babies and young children.

How you can reduce the risk of dehydration

Drink fluids when you feel any dehydration symptoms. Keep taking small sips and gradually drink more if you can.

You can use a spoon to make it easier for your child to swallow the fluids.

You should drink enough during the day so that your pee is a pale clear color.

Drink when there is a higher risk of dehydrating. For example, if you’re vomiting, sweating or you have diarrhoea.

Carers: making sure someone drinks enough

Sometimes people you care for don’t have a sense of how much they’re drinking.

To help them:

• make sure they drink during meal times
• make drinking a social thing like “having a cup of tea”
• offer them food with a high water content – for example, soups, ice cream, jellies or fruits like melon

Children need to stay hydrated

Two thirds of our bodies are made up of water. Being dehydrated can cause poor sports performance, tiredness, headaches and crankiness – and it can lead to serious medical problems.

Signs your child could be dehydrated include:

• dizziness or light-headedness
• nausea
• a headache
• dark yellow or brown urine
• dry lips, tongue, mouth or throat.

What is the best drink to have?

• Water should always be the first choice. Children should be encouraged to keep a water bottle with them at all times and to stop and drink during activity.
• Drinks that contain some carbohydrate (sugar) and extra salts (such as sports drinks) can be useful, but are not always needed.
• Children who are involved in high intensity activity for over an hour, 2-3 times a week may benefit from using sports drinks.
• Have chilled water and sports drink with you on a hot day when children are involved in high intensity exercise. This will help to keep them hydrated and happy
• Sports drinks may be useful during exercise but are not a good choice for general drinking. They are high in sugar and can promote excess energy intake. Water is the best choice!
• Be careful when choosing sports drinks. Some “energy” type drinks may contain other additives such as caffeine. These are not suitable for children.

How much to drink?

• It is hard to work out how much fluid an active child needs on any one day. This is because different amounts of fluid are needed based on the weather and the intensity of the exercise. As a guide:
• A younger child (under 10 years) will need about 200mls of fluid at the start of exercise and at least 100mls for every 20 minutes they are involved in physical activity. This is equal to about a 300ml bottle of water or sports drink every hour.
• Older children (10 years and above) will need double this amount. They will need about 400mls of fluid at the start of exercise and at least 200mls for every 20 minutes they are involved in physical activity. This is equal to about a 600ml bottle of water or sports drink every hour.

Dehydration treatment

If your child is dehydrated, give them more fluid to drink. Water is best. This is especially important during hot weather and when they are exercising. Encourage your child to drink before, during and after exercise.

If they are sick, try to have them drink 1 cup (250ml) of water per hour for 4 hours. If they are vomiting or have diarrhea, try specially prepared children’s rehydration drinks like pedialyte, which you can buy from your local pharmacy.

Babies and young children are more at risk of severe dehydration, which is a medical emergency.

Pedialyte ingredients

Pedialyte Classic Ingredients

Water, Dextrose. Less than 2% of: Citric Acid, Natural & Artificial Flavor, Potassium Citrate, Salt, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Yellow 6.

Pedialyte AdvancedCare Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1.0% of: Galactooligosaccharides, Citric Acid, Potassium Citrate, Salt, Sodium Citrate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Zinc Gluconate, Red 40, and Blue 1.

Pedialyte AdvancedCare Plus Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1% of: Galactooligosaccharides, Salt, Citric Acid, Potassium Citrate, Natural & Artificial Flavor, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Blue 1.

Pedialyte Powder Packs Ingredients (Grape)

Anhydrous Dextrose, Citric Acid, Potassium Citrate, Salt, Sodium Citrate. Less than 2% of: Natural & Artificial Flavor, Beet Powder Color, Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Pedialyte AdvancedCare Plus Powder Packs Ingredients

Anhydrous Dextrose, Short-Chain Fructooligosaccharides, Citric Acid, Salt, Potassium Citrate, Sodium Citrate, Natural & Artificial Flavor. Less than 2% of: Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Pedialyte Freezer Pops Variety Pack Ingredients

Grape (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40, Blue 1), Blue Raspberry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Blue 1), Cherry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40), and Orange (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Yellow 6, Red 40).

Pedialyte nutrition facts

Pedialyte Classic Mixed Fruit

Serving size: 12 fl oz (360 mL)

Amount Per Serving % DV. The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 35
• Total Fat: 0 g (0% DV)
• Sodium: 370 mg (16% DV)
• Total Carbohydrate: 9 g (3% DV)
• Total Sugars: 9 g
• Added Sugars: 9 g (18% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 370 mg (16% DV)
• Potassium: 280 mg (6% DV)
• Zinc: 2.8 mg (25% DV)
• Chloride: 440 mg (20% DV)

Pedialyte Classic Ingredients

Water, Dextrose. Less than 2% of: Citric Acid, Natural & Artificial Flavor, Potassium Citrate, Salt, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Yellow 6.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best when served cold.
• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• Do not add water or dilute.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte AdvancedCare Strawberry Lemonade

Serving size: 12 fl oz (360 mL)

Amount Per Serving % DV. The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 25
• Total Fat: 0 g (0% DV)
• Sodium: 370 mg (16% DV)
• Total Carbohydrate: 6 g (2% DV)
• Total Sugars: 6 g
• Added Sugars: 6 g (12% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 370 mg (16% DV)
• Potassium: 280 mg (6% DV)
• Zinc: 2.8 mg (25% DV)
• Chloride: 440 mg (20% DV)

Pedialyte AdvancedCare Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1.0% of: Galactooligosaccharides, Citric Acid, Potassium Citrate, Salt, Sodium Citrate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Zinc Gluconate, Red 40, and Blue 1.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte AdvancedCare may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte AdvancedCare Plus Berry Frost

Serving size: 12 fl oz (360 mL)

Amount Per Serving % DV. The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 25
• Total Fat: 0 g (0% DV)
• Sodium: 490 mg (21% DV)
• Total Carbohydrate: 6 g (2% DV)
• Total Sugars: 6 g
• Added Sugars: 6 g (12% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 490 mg (21% DV)
• Potassium: 280 mg (6% DV)
• Zinc: 2.8 mg (25% DV)
• Chloride: 630 mg (25% DV)

Pedialyte AdvancedCare Plus Ingredients

Contains milk ingredients.

Water, Dextrose. Less than 1% of: Galactooligosaccharides, Salt, Citric Acid, Potassium Citrate, Natural & Artificial Flavor, Sodium Citrate, Sucralose, Acesulfame Potassium, Zinc Gluconate, and Blue 1.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best when served cold.
• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• Do not add water or dilute.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte Powder Packs Grape

Serving size: 9 g (1/2 packet) prepared with 1 cup [237 mL] water. For ages 4+

Amount Per Serving % DV (Daily Value). The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 25
• Total Fat: 0 g (0% DV)
• Sodium: 240 mg (10% DV)
• Potassium: 180 mg (5% DV)
• Total Carbohydrate: 6 g (2% DV)
• Total Sugars: 6 g
• Protein: 0g (0% DV)

Minerals

• Sodium: 10.6 mEq
• Potassium: 4.7 mEq
• Chloride: 294 mg
• Chloride: 8.3 mEq (8% DV)

Pedialyte Powder Packs Ingredients (Grape)

Anhydrous Dextrose, Citric Acid, Potassium Citrate, Salt, Sodium Citrate. Less than 2% of: Natural & Artificial Flavor, Beet Powder Color, Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Use under medical supervision

• Pedialyte Powder Packs and Freezer Pops are NOT for use for children under 1 year of age.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 4 – 8 servings (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best served cold.
• Reconstitute only with water.
• Mix one pack of Pedialyte Powder with 16 fl oz (2 cups) water. Stir to dissolve.
• Store unused, reconstituted product in sealed container in refrigerator for up to 24 hours.
• Do not store powder packs at extreme temperatures.

Pedialyte AdvancedCare Plus Powder Packs (Strawberry Freeze)

Serving size: 17 g (1 Packet)

Amount Per Serving % DV (Daily Value). The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 30
• Total Fat: 0 g (0% DV)
• Sodium: 650 mg (28% DV)
• Potassium: 370 mg (8% DV)
• Total Carbohydrate: 8 g (3% DV)
• Total Sugars: 8 g
• Added Sugars: 8 g (16% DV)
• Protein: 0g (0% DV)

Minerals

• Sodium: 650 mg (28% DV)
• Potassium: 370 mg (8% DV)
• Chloride: 840 mg (35% DV)

Pedialyte AdvancedCare Plus Powder Packs Ingredients

Anhydrous Dextrose, Short-Chain Fructooligosaccharides, Citric Acid, Salt, Potassium Citrate, Sodium Citrate, Natural & Artificial Flavor. Less than 2% of: Calcium Silicate, Acesulfame Potassium, Sucralose, and Blue 1.

Use under medical supervision

• For infants under 1 year of age: Consult your doctor.
• For children 1 year and older and adults: Begin with small frequent sips every 15 minutes, increasing serving size as tolerated. Continue for as long as diarrhea is present.
• To maintain proper hydration, 1-2 liters (32 to 64 fl oz) of Pedialyte may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continues beyond 24 hours or if consumption needs are greater than 2 liters (64 fl oz) per day.

Directions of use

• Tastes best when served cold.
• Do not use if printed band around cap or inner foil seal is missing or broken.
• Remove protective band and twist off cap.
• Remove and throw away protective foil seal.
• Do not add water or dilute.
• After opening, replace cap, refrigerate and use within 48 hours.
• Store unopened bottles in a cool place. Avoid excessive heat.
• Do not reuse bottle.

Pedialyte Freezer Pops Variety Pack

• Grape, Blue Raspberry, Cherry, and Orange

Serving size: 63 mL (1 pop). Children over 4 and adults

Amount Per Serving % DV (Daily Value). The % Daily Value (DV) tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.

Nutrition Information

• Calories: 5
• Total Fat: 0 g (0% DV)
• Sodium: 65 mg (3% DV)
• Potassium: 50 mg (1% DV)
• Total Carbohydrate: 2 g (1% DV)
• Total Sugars: 2 g
• Protein: 0g (0% DV)

Minerals

• Chloride: 2.2 mEq (2% DV)

Pedialyte Freezer Pops Variety Pack Ingredients

Grape (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40, Blue 1), Blue Raspberry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Blue 1), Cherry (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Red 40), and Orange (Water, Anhydrous Dextrose; Less than 2% of: Citric Acid, Salt, Sodium Carboxymethylcellulose, Potassium Citrate, Potassium Sorbate, Sodium Benzoate, Natural & Artificial Flavor, Sucralose, Acesulfame Potassium, Yellow 6, Red 40).

Use under medical supervision

• Pedialyte Powder Packs and Freezer Pops are NOT for use for children under 1 year of age.
• For children 1 year and older and adults: Offer Pedialyte Freezer Pops as frequently as desired.
• To maintain proper hydration, 16 to 32 Freezer Pops (or a total of 32 to 64 fl oz of any Pedialyte product) may be needed per day. Consult your doctor if vomiting, fever, or diarrhea continue beyond 24 hours or if consumption needs are greater than 32 Freezer Pops (64 fl oz) per day.
• Freezer Pops can be consumed without freezing, but the flavors are best when frozen.
• NOTE: Like colored ices, Pedialyte Freezer Pops may temporarily color mouth.

Directions of use

•  To eat frozen
  • Remove Pops from carton and freeze before separating.
  • Tear or cut carefully between sleeves along perforations.
  • Cut off top of sleeve.
• To drink
  • Cut carefully between sleeves along perforations.
  • Cut off top of sleeve and pour liquid into cup or glass and drink.
  • Discard unused portion of opened product.
  • Do not reuse plastic sleeves.
  • Store unopened pops in cool place. Avoid excessive heat.

Is pedialyte good for you

Pedialyte is a medical-grade rehydration solution. It is good for adding back fluid after fluid loss or to help prevent fluid and electrolyte problems during bouts of diarrhea or vomiting.

Can you drink pedialyte everyday

Pedialyte is a medical-grade rehydration solution that is meant to treat serious dehydration caused by vomiting or diarrhea and is not meant to be used everyday. Furthermore, Pedialyte drinks are usually high in kilojoules (energy) and added sugar and provide very few nutrients. They can also contribute to poor nutrition, tooth decay and weight gain.

It is really important to limit the number of sugary drinks that you and your children have and to encourage them to have healthier options like water. Drinking water is the best way to quench a thirst – and it doesn’t come with the sugar and the kilojoules.

Pedialyte vs Gatorade

Pedialyte is a medical-grade rehydration solution. It is good for adding back fluid after fluid loss or to help prevent fluid and electrolyte problems during bouts of diarrhea or vomiting.

Gatorade is a sports beverage like other sports beverages are designed to give athletes carbs, electrolytes, and fluid during high-intensity workouts that last an hour or more. For average people, they’re just another source of sugar and calories.

Sports drinks provide a simple and effective way to replace fluid and carbohydrate simultaneously during exercise. Of course, specialized products such as Gatorade are expensive and are best used in the right sporting situation. Some people use cordial or carbohydrate foods such as fruit, bars, confectionary or sandwiches to provide a fuel boost during exercise. A carbohydrate intake of about 50 g per hour is generally recommended for prolonged events. Successful strategies are ultimately decided by individual preferences and experience.

Water is a cheap and readily available fluid, and is often quoted to be the “best” drink for active people. However, carbohydrate intake is known to improve performance during events of longer than 90 minutes, by providing the muscles and brain with extra fuel. Recently a number of studies have shown that carbohydrate intake may also be of benefit for a workout of as little as one hour. It certainly won’t harm performance, although some individuals may need to count the cost or the kilojoules involved.

Examples of 50g carbohydrate snacks include:

• 750 mL sports drink or cordial
• 500 mL fruit juice or soft drink
• 250 mL og liquid meal supplement (eg. Sustagen)
• 250 mL fruit smoothie
• 3 medium pieces of fruit
• honey or jam sandwich
• 60g packet of jelly beans or jubes
• 1 carton of fruit yoghurt + 250 mL of fruit juice
• bowl cereal + skim milk
• carton of fromage frais + granola bar

Pedialyte side effects

There are no known drug interactions for Pedialyte (electrolyte replacement solutions). However, this does not necessarily mean no interactions exist. Always consult with your doctor or pharmacist.

Applies to electrolyte replacement solutions: oral packet, oral powder for solution, oral powder for suspension, oral solution, oral tablet

Along with its needed effects, electrolyte replacement solutions (the active ingredient contained in Pedialyte) 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 as soon as possible if any of the following side effects occur while taking electrolyte replacement solutions:

Symptoms of too much sodium (hypernatremia) in the body

• Convulsions (seizures)
• dizziness
• fast heartbeat
• high blood pressure
• irritability
• muscle twitching
• restlessness
• swelling of feet or lower legs
• weakness

Symptoms of too much fluid in the body

• Puffy eyelids

Some side effects of electrolyte replacement solutions 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:

More common

• Vomiting (mild)

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 fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.

1. What is Pedialyte? https://pedialyte.com/what-is-pedialyte
2. Infants and Children: Management of Acute Gastroenteritis, Fourth Edition 19-Dec-2014. http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/GL2014_024.pdf
3. New formula oral rehydration salts. http://apps.who.int/medicinedocs/en/d/Js4950e/2.4.html
4. Aperia A. et al. Salt and water homeostasis during oral rehydration therapy. J Pediatr 1983;103:364-69
5. Booth I, Ferreira R, Desjeux JF et al. Recommendation for composition of oral rehydration solutions for the children of Europe. Report of an ESPGAN working group. J Pediatric Gastroenterology and Nutrition. 1992;14:113-115.
6. International Study Group on Reduced-osmolarity ORS solutions. Multicentre evaluation of reduced-osmolarity oral rehydration salts solution. Lancet. 1995;345:282-285.
7. Assessing the Palatability of Oral Rehydration Solutions in School-aged ChildrenA Randomized Crossover Trial. Arch Pediatr Adolesc Med. 2010;164(8):696-702. doi:10.1001/archpediatrics.2010.129 https://jamanetwork.com/journals/jamapediatrics/fullarticle/383602