Pediacare Infants Fever Reducer Cherry
FDA Label NDC 52183-393

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Pediacare Infants Fever Reducer Cherry (NDC 52183-393). 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 ingredients, 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.

Label Section Quick Index

Active Ingredients

(in each 0.8 mL)

Acetaminophen 80mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen.

    • 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 product 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 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 away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not give more than directed (see overdose warning)
  • shake well before use
  • this product does not contain directions or complete warnings for adult use
  • use only with enclosed dosing device
  • fill to dose level
  • dispense liquid slowly into child’s mouth towards inner cheek
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • use dropper to close bottle and maintain child resistance
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • Weight (lb)Age (yr)Dose (mL)
    Under 24Under 2ask a doctor
    24-352-31.6 mL (0.8 + 0.8 mL)

Other Information

store between 20-25°C (68-77°F)

Inactive Ingredients:

butyl paraben, citric acid, FD&C Red #40, flavor, glycerin, maltitol, propylene glycol, propyl paraben, purified water, sucralose, xanthan gum.

Questions Or Comments?

call 1-888-474-3099

Distributed by:
Blacksmith Brands Inc.
200 White Plains Road
Tarrytown, NY 10591 USA
© 2010

Principal Display Panel

NEW PediaCare® Infants
Fever Reducer Pain Reliever
Ludens® Cherry Taste!
1 FL OZ (30 mL)

Principal Display Panelpediacare Infants Fever Reducer Cherry Flavor (Pediacare Infants Fever Reducer Cherry 01)

Principal Display Panelpediacare Infants Fever Reducer Cherry Flavor (Pediacare Infants Fever Reducer Cherry 01)

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