Firstcare Childrens Pain Fever Acetaminophen Tablet, Chewable
FDA Label NDC 71594-702

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uspharma Ltd for the product Firstcare Childrens Pain Fever Acetaminophen (NDC 71594-702). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each chewable tablet), purpose, uses, warnings, do not use, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Chewable Tablet)

Acetaminophen 80 mg

Purpose

Pain reliever/fever reducer

Uses

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

Warnings

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.

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.

Directions

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • Instruct child to chew each piece thoroughly before swallowing
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours 

    • Weight (lbs.)

    Age (yrs.)

    Dose (chewable tablet)*

    Under 24

    Under 2 years

    Ask a doctor

    24-35

    2-3 years

    2 chewable tablets

    36-47

    4-5 years

    3 chewable tablets

    48-59

    6-8 years

    4 chewable tablets

    60-71

    9-10 years

    5 chewable tablets

    72-95

    11 years

    6 chewable tablets

    * or as directed by a doctor

Other Information

  • each chewable tablet contains:calcium 5 mg, magnesium 5 mg, potassium 10 mg, sodium 5 mg.

    •       low sodium

    • Store in a cool dry place between 20-25°C (68-77°F).
    • Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive Ingredients

artificial flavors, corn syrup, D&C red no. 33, geleol mono and diglycerides, hydroxypropyl betadex, maltodextrin, monobasic potassium phosphate, pregelatinized starch, purified water, seaweed extract (carrageenan), sodium chloride, stevia sweetener, sucralose, sucrose.

Questions Or Comments?

Call 1-800-227-6151

Principal Display Panel - Firstcare Children's Pain + Fever Acetaminophen 80 Mg

NDC 71594-702-13

FIRSTCARE

CHILDREN'S

Pain + Fever

ACETAMINOPHEN 80 mg

Pain Reliever

Fever Reducer

24 Chewable               Cherry Flavor

Tablets

* Please review the disclaimer below.