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Pain and Fever (acetaminophen 80 mg) Dailymed

  1. Human OTC
  2. Prostaglandin Receptor Antagonists
  3. A-S Medication Solutions

Generic: acetaminophen is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain

Pain and Fever tablet, chewable - (acetaminophen 80 mg) image

IMPRINT: 1G     SHAPE: round
    COLOR: pink

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SAVE CARTON FOR COMPLETE DRUG FACTS

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 pains 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 other drug containing acetaminophen (prescription or non prescription). 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.

OVERDOSAGE SECTION


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 product does not contain directions or warnings for adult use.
  • find right dose on 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 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

Storage And Handling Section


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

Inactive Ingredient Section


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

Otc - Questions Section


Questions or comments?

Call 1-800-645-2158


Distributed by: Rugby Laboratories

17177 N. Laurel Park Drive, Suite 233

Livonia, MI 48152

www.rugbylaboratories.com

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

How Supplied


Product: 50090-3463

NDC: 50090-3463-0 30 TABLET, CHEWABLE in a BOTTLE, PLASTIC / 1 in a CARTON

Acetaminophen


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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