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Generic: acetaminophen


IMPRINT: 1G     SHAPE: round
    COLOR: pink

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Drug Facts

Otc - Active Ingredient Section


Active ingredient (in each chewable tablet)

Acetaminophen 80 mg

Otc - Purpose Section


Purposes

Pain Reliever/Fever Reducer

Indications & Usage Section


Uses
  • temporarily relieves minor aches and pain due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache
  • temporarily reduces fever.

Warnings Section


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
  • bulers
  • 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.

Otc - Do Not Use Section


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

Otc - Ask Doctor Section


Ask a doctor before use if your child has liver disease.

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using Section


When using this product, do not exceed recommended dose (see overdose warning)

Otc - Stop Use Section


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.

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Dosage & Administration Section


Directions
  • this products does not contain directions or complete warnings for adult use.
  • find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor.
Weight Age Dosage
Under 24 lbs Under 2 years Ask a doctor
24-35 lbs 2-3 years 2 tablets
36-47 lbs 4-5 years 3 tablets
48-59 lbs 6-8 years 4 tablets
60-71 lbs 9-10 years 5 tablets
72-95 lbs 11 years 6 tablets


Other information
  • Phenylketonurics: Contain Phenylalanine 14 mg per tablet
  • Store at room temperature in a dry place

Inactive Ingredient Section


Inactive ingredients Aspartame, Colloidal Silica, D&C Red # 27 Lake, Hypromellose, Magnesium Stearate, Mannitol, Natural & Artificial Berry Flavors, Povidone, Pregelatinized Starch, Sodium Chloride, Sodium Starch Glycolate, Sorbitol, Stearic Acid and Sucralose.

Otc - Questions Section


Questions or comments?

Call: (800) 616-2471


Distributed by:

MAJOR PHARMACEUTICALS

17177 N LAUREL PARK DRIVE, SUITE 233

LIVONIA, MI 48152

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Package Label.principal Display Panel


MAJOR® NDC 0904-5256-46 See New Warnings Information Children's Chewable Mapap Acetaminophen Fever reducer/ Pain reliever ASPIRIN FREE ● IBUPROFEN FREE

NATURAL & ARTIFICIAL BERRY FLAVORS 30 Tablets, 80 mg EACH

AGES 2-11



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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