Pediacare Childrens Acetaminophen Grape Suspension
FDA Label NDC 52412-906

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Randob Labs,ltd. Dba Crossingwell Consumer Health for the product Pediacare Childrens Acetaminophen Grape (NDC 52412-906). 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), 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

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.

    Distributed by
    CrossingWell
    Consumer Health
    PO Box 440
    Cornwall, NY 12518

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

  • 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 for adults as well as for children 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
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • only use enclosed measuring syringe
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
    • Weight (lb)Age (yr)Dose (mL)

    or as directed by doctor

    under 24under 2 yrask a doctor
    24-352-3 yr5 mL

Other Information

  • Store between 15° - 30° C (59° - 86° F)
  • Protect from Freezing
  • Protect from Light

Inactive Ingredients

acesulfame potassium, citric acid, corn syrup, FD&C blue #1, FD&C red #33 flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Principal Display Panel - 30 Ml Bottle Carton

Fast Acting
Pedia
Care®
100% dedicated
to kids™

Infants

ACETAMINOPHEN

Pain Reliever/
Fever Reducer

Acetaminophen (160 mg per 5mL)
Oral Suspension

Alcohol Free, Asprin Free
Ibuprofen Free, No Parabens

Grape Flavor
(Use Only Enclosed Syringe)

1 FL OZ (30mL)
160 mg per 5 mL

Principal Display Panel (30 mL Bottle Carton)

Principal Display Panel (30 mL Bottle Carton)

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