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ACETAMINOPHEN 80 MG FRUIT CHEW (acetaminophen 80 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Reliable 1 Laboratories LLC

Generic: acetaminophen

ACETAMINOPHEN 80 MG FRUIT CHEW tablet - (acetaminophen 80 mg) image

IMPRINT: AP 051     SHAPE: round
    COLOR: pink    SCORE: 2

  1. FDA Adverse Reactions

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Drug Facts

Active Ingredient (in Each Tablet)


Acetaminophen USP, 80 mg

Purposes


Pain Reliever/Fever Reducer

Uses


temporarily reduces fever and relieves minor aches and pains caused by
  • headache
  • the common cold
  • flu
  • toothache
  • sore throat

Warnings


Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes
  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

Other Safety Information


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.

Other Safety Information


Sore throat warning: If sore throat is severe, lasts for more than 2 days or 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 wheater a drug contains acetaminophen, ask a doctor or pharmacist.

Otc - Ask Doctor Section


Ask a doctor before use if the child has liver disease

Otc - Ask Doctor/pharmacist Section


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

Drug Facts continued on back of label

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
  • redness or swelling is present
  • any new symptoms appear

These could be signs of a serious condition

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see Overdose warning)
  • find correct dose on chart below
  • if possible, use weight to dose, otherwise use age
  • chew tablets before swallowing
  • give dose every 4 hours while symptoms last
  • do not give more than 5 doses in 24 hours
Weight (pounds) Age (years) Dose (tablets)
72-95 11-12 4-6

60-71
 9-10 4-5
48-59 6-8 4
36-47 4-5 3
24-35 2-3 2
under 24 under 2 ask a doctor

Other Information

  • Phenylketonurics: each tablet contains: phenylalanine 5 mg

Other Information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients


aspartame, compressible sugar, D&C red #27 (Al-lake), dextrose, FD&C yellow #6 (Al-lake), flavors, magnesium stearate, microcrystalline cellulose, stearic acid

Questions Or Comments?


call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday


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


*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Package Label.principal Display Panel


NDC 69618-012-03

FRUIT FLAVORED

Acetominophen USP 80 mg

PAIN RELIEVER

FEVER REDUCER

30 CHEWABLE TABLETS

*Compare to Active Ingredient in Children's TYLENOL®

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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