Qaulity Choice Pain Relief Extra Strength
FDA Label NDC 63868-564

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Qaulity Choice Pain Relief Extra Strength (NDC 63868-564). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Acetaminophen 500 mg

Otc - Purpose

Purpose

Pain Reliever/Fever Reducer

Indications & Usage

Uses

  • temporarily relieves minor aches and pains
    • temporarily reduces fever

Warnings

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablespoonfuls in 24 hours. Sever liver damage may occur if you take

  • more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyd ay while using this product

    • Allergy alert: acetaminophen may cause sever skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash
    • If a skin reaction occurs, stop use and seek mdical help right away.

      • 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 you are allergic to acetaminophen or any of the inactive ingredients in thris product.
      Ask a doctor before use if you have liver disease
      Ask a doctor before use if you are taking the blodd thinning drug warfarin.
      When using this product: Do not exceed recomended dose.
      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 symptoms occur
      • redness or swelling is present

        • These could 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. In case of overdose, get midcal help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Dosage & Administration

Directions Do not take more than directed

 Age Dose
 Adults and children12 years of age and older Take 1 to 2 tablespoonfuls every 4 to 6 hours as needed. not more than 6 tablespoonfuls in 24 hours
 Children under 12 years Do not use

Inactive Ingredient

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, porpylparaben, purified water, sodium citrate, sucralose.

Otc - Questions

Question or comments? 1-800-540-3765

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