Extra Strength Pain Relief Tablet
FDA Label NDC 63629-1516

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 Extra Strength Pain Relief (NDC 63629-1516). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • more than 8 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

    • 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.
      • Ask a doctor before use if you have liver disease.
      Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

      Stop use and ask a doctor if

      • pain gets worse or lasts more than 10 days
      • fever gets worse or lasts more than 3 days
      • new symptom occur
      • redness or swelling is present
        • These could be signs of a serious condition.

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

        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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • do not take more than directed
  • adults and children 12 years and over: take 1-2 tablets every 4-6 hours, as needed; not more than 8 tablets in 24 hours
  • children under 12 years: do not use

Other Information

  • TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
  • store at 20⁰C-25⁰C (68⁰F-77⁰F)
  • for institutional use only

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid. May also contain: crospovidone, methylparaben and probylparaben


Package Label.Principal Display Panel

Acetaminophen 500mg Tablet

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