Little Remedies Childrens Fever Pain Reliever Liquid
FDA Label NDC 63029-603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Remedies Childrens Fever Pain Reliever (NDC 63029-603). 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, purpose, uses, warnings, do not use, ask a doctor before use, ask a doctor or pharmacist before use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain Reliever/Fever Reducer

Uses

Temporarily:

  • reduces fever
  • relieves minor aches and pains which may be associated with the common cold, flu, headache, sore throat or 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 maximum daily amount
  • with other drugs containing acetaminophen.
  • Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If 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, or is accompanied or followed by fever, headache, rash nausea or vomiting, consult a doctor promptly.

Do Not Use

  • with any other products 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.

Ask A Doctor Before Use

if your child has liver disease.

Ask A Doctor Or Pharmacist Before Use

if the child is taking the blood thinning drug warfarin.

When Using This Product

do not exceed recommended dosage (see overdose warning).

Stop Use And Ask A Doctor If

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

Overdose Warning

Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of 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.
  • Find the right dose on the chart below. (If possible, use weight to determine dosing; otherwise, use age.)
  • Pour liquid into AccuSafe® dosing cup to the appropriate amount for your child's weight and/or age.
  • Only use with enclosed AccuSafe® dosing cup.
  • If needed, repeat dose every 4 hours while symptoms last.
  • Do not give more than 5 days in any 24-hour period (see overdose warning).
  • Do not give more than 5 days unless directed by a doctor.
  • Replace cap tightly to maintain child resistance.
  • Weight (lb)Age (yr)Dose
    Under 24under 2Ask a doctor
    24-352 – under 45mL
    36-474 – under 67.5mL
    48-596 – under 910 mL
    60-719 – under 1112.5mL
    72-9511 – under 12 15mL

Other Information

  • Store at 20-25°C (68-77°F)
  • AccuSafe® Dosing cup enclosed.
  • Check expiration date on bottle or box before using.
  • Tamper Evident: DO NOT USE if printed shrink band on bottle is broken or missing.

Inactive Ingredients

citric acid, glycerin, natural flavors, potassium sorbate, povidone, propylene glycol, purified water, sodium citrate, sucralose, sucrose, xanthan gum

Questions?

1-800-754-8853

Mon. – Fri. 8:00 a.m. to 8:00 p.m. EST   LittleRemedies.com.

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Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
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4 FL OZ (118 mL)

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CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
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4 FL OZ (118 mL)

Little Remedies Childrens Fever Grape Carton (Little Fevers Childrens Fever Pain Reliever Grape)

Little Remedies Childrens Fever Grape Carton (Little Fevers Childrens Fever Pain Reliever Grape)

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