Kids Pain And Fever Suspension
FDA Label NDC 82673-104

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kinderfarms, Llc for the product Kids Pain And Fever (NDC 82673-104). 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 5 ml), purpose, uses, other, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

Other

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
    • blisters
    • 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.

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

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 your child is taking the blood thinning drug warfarin.

Otc - When Using

When using this product, do not exceed recommended dose (see Overdose warning).

Stop Use And Ask A Doctor If

  • any new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

    • 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 (1-800-222-1222) right away. Prompt 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
  • do not give more than directed (see Overdose warning)
  • shake well before using
  • mL = milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • 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
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

    • *or as directed by a doctor

    Weight (lb)Age (years)Dose (mL)*
    under 24 under 2 ask a doctor
    24-35 2-3 5 mL
    36-47 4-5 7.5 mL
    48-59 6-8 10 mL
    60-71 9-10 12.5 mL
    72-95 11 15 mL

Other Information

  • Each 5mL contains: sodium 10mg
  • store between 20-25˚C (68-77˚F)
  • do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive Ingredients

Organic agave syrup, non-GMO ascorbic acid (vitamin C), organic cherry flavor, glycerin, natural flavor, non-GMO sodium citrate

DISTRIBUTED BY: KinderFarms®
Redondo Beach, CA 90277 USA
kinderfarms.com

Principal Display Panel - 118 Ml Carton Label

KinderMed®

Same active ingredient as
Children's Tylenol®†

Ages
2-11 yrs.

KIDS'
PAIN & FEVER
Acetaminophen

160 mg per 5 mL Oral Suspension

Pain Reliever | Fever Reducer

Organic Cherry Flavor

NON
GMO
Project

VERIFIED

nongmoproject.org

NO DYES.

NO ARTIFICIAL FLAVORS.

NO ARTIFICIAL SWEETENERS.

DOSING CUP INCLUDED

4 FL OZ (118 mL)

Principal Display Panel (118 mL Carton Label)

Principal Display Panel (118 mL Carton Label)

* Please review the disclaimer below.