Feverall Suspension
FDA Label NDC 51672-5319

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Feverall (NDC 51672-5319). 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), purposes, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

    Dist. by: Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily:

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

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

  • 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.

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.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • 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.
  • Weight (lb)Age (yr)Dose (mL)

    or as directed by a doctor

    under 24under 2 yearsask a doctor
    24-35 lbs2-3 years5 mL
    36-47 lbs4-5 years7.5 mL
    48-59 lbs6-8 years10 mL
    60-71 lbs9-10 years12.5 mL
    72-95 lbs11 years15 mL

    Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • each 5 mL contains: sodium 3 mg
  • store between 20 to 25°C (68 to 77°F)
  • do not refrigerate
  • Keep carton for full directions for use.

Inactive Ingredients

anhydrous citric acid, butylparaben, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Principal Display Panel - 118 Ml Bottle Carton

NEW

ORAL
SUSPENSION
LIQUID

NDC 51672-5319-8

CHILDREN'S
ages 2-11 years

FeverAll®
ACETAMINOPHEN (160 mg/5 mL)

Pain Reliever/Fever Reducer
Oral Suspension

Cherry Flavor

DOSING CUP
ENCLOSED

4 FL OZ (118 mL)

Principal Display Panel (118 mL Bottle Carton)

Principal Display Panel (118 mL Bottle Carton)

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