Childrens Pain Relief
FDA Label NDC 68016-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium (premier Value) for the product Childrens Pain Relief (NDC 68016-103). 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 other, active ingredient (in each 5 ml, 1 teaspoon), purpose, uses, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

Active Ingredient (In Each 5 Ml, 1 Teaspoon)

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

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

Do Not Use

  • with any 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

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

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

Stop Use And Ask A Doctor If

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Overdose Warning

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical 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
  • find right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • tsp = teaspoon, mL = milliliter
  • 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 (lb)Age (yr)Dose (tsp or mL)
    under 24under 2ask a doctor
    24-352-31 tsp or 5 mL
    36-474-51½ tsps or 7.5 mL
    48-596-82 tsps or 10 mL
    60-719-102½ tsps or 12.5 mL
    72-95113 tsps or 15 mL

Other Information

  • store at controlled room temperature
  • dosage cup provided
  • each teaspoon contains: sodium 2 mg

Inactive Ingredients

Carboxymethylcellulose, FD & C Red # 40, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions Or Comments?

1-732-249-6363

Principal Display Panel - 118 Ml Bottle Label

NDC 68016-103-04

Premier
Value ®

Children's
Pain Relief
PAIN RELIEVER - FEVER REDUCER
ACETAMINOPHEN
SUSPENSION DROPS

  • Alcohol Free
  • Aspirin Free
  • Ibuprofen Free

    • Cherry
    Flavor

    4 FL OZ (118 mL)

    INDEPENDENTLY TESTED
    PV
    SATISFACTION GUARANTEED

    Principal Display Panel (118 mL Bottle Label)

    Principal Display Panel (118 mL Bottle Label)

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