Feverall Suppository
FDA Label NDC 51672-2115

14 label sections · Submitted to the FDA by Sun Pharmaceutical Industries, Inc. · 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 51672-2115). 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, do not use, ask a doctor before use if, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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.

    For rectal use only.

    Dist. by: Ohm Laboratories, Inc.
    New Brunswick, NJ 08901

Active Ingredient (In Each Rectal Suppository)

Acetaminophen, USP 120 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 your child takes

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

Do Not Use

  • 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

  • the child has liver disease.
  • the child is taking the blood thinning drug warfarin.

Stop Use And Ask A Doctor If

  • fever lasts more than 3 days (72 hours), or recurs.
  • pain lasts more than 5 days or gets worse.
  • new symptoms occur.
  • redness or swelling is present in the painful area.

    • These may be signs of a serious condition.

Directions

  • this product does not contain directions or warnings for adult use
  • do not use more than directed
  • remove wrapper
  • carefully insert suppository well up into the rectum
    • Dosing Chart
    AgeDose
    under 3 yearsDo not use unless directed by a doctor
    3 to 6 yearsUse 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

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?

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