Feverall
FDA Label NDC 63629-8240

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Feverall (NDC 63629-8240). 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 rectal suppository), purposes, uses, liver warning, otc - stop use, do not use, ask a doctor before use if, 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

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

Active Ingredient (In Each Rectal Suppository)

Acetaminophen, USP 325 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

  • reduces fever
  • relieves minor aches, pains, and headache

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if

  • a child 6 to 12 years takes more than 5 doses in 24 hours
  • an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • an adult takes 3 or more alcoholic drinks everyday while using this product

Otc - Stop Use

If a skin reaction occurs, stop use and seek medical help right away.

For rectal use only.

Do Not Use

  • in children under 6 years
  • if you are allergic to acetaminophen.
  • with any other drug containing acetaminophen (prescription or nonprescription).
    If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask A Doctor Before Use If

  • you have liver disease.
  • you are taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain gets worse or lasts more than 10 days.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

    • These may be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Directions

  • remove wrapper
  • do not use more than directed
  • carefully insert suppository well up into the rectum
    • Dosing Chart
    AgeDose
    under 6 yearsdo not use
    6 to 12 yearsUse 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours)
    adults and children 12 years and olderUse 2 suppositories every 4 to 6 hours. (maximum of 6 doses)

Other Information

  • store at 2°-27°C (35°-80°F)
  • do not use if imprinted suppository wrapper is opened or damaged

Inactive Ingredients

glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80

Questions?

call 1-866-923-4914

How Supplied

Product: 63629-8240

NDC: 63629-8240-1 12 SUPPOSITORY in a BOTTLE

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