Extra Strength Pain Relief
FDA Label NDC 63868-863

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 Extra Strength Pain Relief (NDC 63868-863). 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 ingredient (in each softgel), purpose, uses, warnings, do not use, stop use and ask a doctor if, overdose warning, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Softgel)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • the common cold
    • headache
    • backache
    • minor pain of arthritis
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

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.

Overdose Warning

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

  • do not take more than directed (see Overdose warning)

    • adults and children 12 years of age and over

    • take 2 softgels every 6 hours while symptoms last
    • do not take more than 6 softgels in 24 hours unless directed by a doctor
    • do not use for more than 10 days unless directed by a doctor

    children under 12 years of age

         ask a doctor

Other Information

  • store at room temperature 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call: 248-449-9300

Principal Display Panel - 40Ct

Extra Strength Pain Relief

Acetaminophen, 500mg 40 Liquid Gels

NDC 63868-863-40

*Compare to the active ingredient in TYLENOL® Extra Strength

Principal Display Panel - 80Ct

Extra Strength Pain Relief

Acetaminophen, 500mg 80 Liquid Gels

NDC 63868-863-80

*Compare to the active ingredient in TYLENOL® Extra Strength

* Please review the disclaimer below.