Childrens Pain And Fever Liquid
FDA Label NDC 53943-526

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Childrens Pain And Fever (NDC 53943-526). 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 drug factsactive ingredient(in each 5 ml = 1 teaspoonful), purpose, uses, warnings, do not use, ask a doctor if your child has, ask a doctor or pharmacist before use if your child is, when using this product do not exceed recommended dose., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient(In Each 5 Ml = 1 Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily

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

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 maxium daily amount
  • with other drugs containing acteaminophen

    • Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

    • skin reddening
    • blisters
    • rash

      • If a skin reaction occurs, stopuse and seek medical help right away.

      Sore throat warning: If a sore throat is severe, persiss 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 to any of the inactive ingredients in this product

Ask A Doctor If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

When Using This Product Do Not Exceed Recommended Dose.

(see overdose warnings)

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.

Keep out of reach of children.

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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.
  • shake well before using
  • mL = millititer; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose, otherwise, use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give for more than 5 days unless directed by a doctor

    • Weight (lb)        Age (yr)            Dose (mL or Tsp)*
    under 24           under 2 years    ask a doctor

    24-35               2-3 years           5 mL (1 tsp)

    36-47               4-5 years           7.5 mL (1 1/2 tsp)

    48-59               6-8 years           10 mL (2 tsp)

    60-71               9-10 years          12.5 mL (2 1/2 tsp)

    72-95               11 years              15 mL

    * or as directed by a doctor

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

Other Information

  • eash 5mL (1 tsp) contains sodium 3mg
  • store between 20-25

Inactive Ingrediants

anhydrous citric acid, butylparaben, D&C Red # 33, FD&C (red), flavor, glycerin, flavor, high frucotose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum   

Questions

Call weekays from 9:30 AM to 4:30 PM

Children's Pain & Fever Product Label

DISCOUNT
drug mart
FOOD FAIR

COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL® ORAL SUSPENSION

Fever Reducer / Pain Reliever

Children's Pain & Fever

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Aspirin Free

    • For Ages 2 to 11

    GRAPE FLAVOR

    4 FL OZ (118 mL)
    160 mg per 5 mmL

    * This product is not manufactures or distributed by McNeil Consumer Healthcare, distribbutor of Children's Tylenol® Oral Suspension.

    BX-053

    SATISFACTION GUARANTEED

    IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

* Please review the disclaimer below.