Little Remedies Infant Fever/pain Reliever Liquid
FDA Label NDC 63029-610

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 Infant Fever/pain Reliever (NDC 63029-610). 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:, stop use and ask a doctor if, keep out of reach of children., directions, 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.

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.

Keep Out Of Reach Of Children.

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 (1-800-222-1222) immediately. 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
    • find the right dose on the chart below. (If possible, use weight to determine dose; otherwise, use age.)
    • only use the enclosed AccuSafe®syringe
    • remove cap, insert syringe to flow restrictor and invert bottle
    • pull back syringe until filled to prescribed level and slowly dispense the liquid into your child’s mouth (toward the inner cheek)
    • if needed, repeat dose every 4 hours while symptoms last
    • do not give more than 5 times in any 24-hour period
    • replace cap tightly to maintain child resistance
    • mL=mililiter

      Weight (lbs)Age (yrs)Dose
      Under 24Under 2Ask a doctor
      24-352-35 mL

Other Information

  • each 5 mL contains: sodium 6 mg
  • store at 20-25°C (68-77°F)
  • AccuSafe® dosing device enclosed
  • check expiration date on bottle or box before using

Inactive Ingredients

benzoic acid, carboxymethlcellulose, glycerin, natural berry flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum

Questions?

1-800-54-8853 Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST

LittleRemedies.com

Principal Display Panel


Little Remedies®
INFANT

FEVER+PAIN RELIEVER
Acetaminophen 160 mg / 5 mL

natural berry flavor
2 FL OZ (59 mL)

Principal Display Panellittle Remedies®infantfever+pain Relieveracetaminophen 160 mg / 5 mLnatural Berry Flavor2 Fl Oz (59 mL) (Little Remedies Infant Fever Pain Reliever   Berry 01)

Principal Display Panellittle Remedies®infantfever+pain Relieveracetaminophen 160 mg / 5 mLnatural Berry Flavor2 Fl Oz (59 mL) (Little Remedies Infant Fever Pain Reliever Berry 01)

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