Childrens Pain And Fever Liquid
FDA Label NDC 68998-525

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Childrens Pain And Fever (NDC 68998-525). 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, purpose, keep out of reach of children., uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliver/fever reducer

Keep Out Of Reach Of Children.

Keep out of reach of children.

Uses

temporarily reduces

  • fever
  • relieves minor aches and pains 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 conntaining acetaminophen

    • 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.

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.

Ask A Doctor Before Use 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 Warning)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.

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 awway. (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 = milliliter; 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 more than 5 times in 24 hours
  • 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 (3 tsp)

    * or use as directed

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

Other Information

  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive Ingredients

anhydrous citric acid, butylparaben, FD and C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Marcs Childrens Pain And Fever Product Label

NDC 68998-525-24

Compare to the active ingredient in childrens Tylenol® oral suspension*

MARCS

Childrens

Pain and Fever

Pain Reliver / Fever Reducer

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Asprin Free

    • For Ages 2 to 11

    CHERRY FLAVOR

    4 FL OZ (118 mL)

    160 mg per 5 mL

    DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

    * This product is not manufactured or distributed by McNeil Consumer Healthcare, Distributer of Childrens Tylenol® Oral Suspension

    Distributed by:

    Marc Glassman, Inc.

    West 130th Street

    Cleveland, OH 44130

    BX-045

    LR-076

    Lot:

    Exp:

* Please review the disclaimer below.