Acetaminophen
FDA Label NDC 53598-003

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bonita Pharmaceuticals Llc for the product Acetaminophen (NDC 53598-003). 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, purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, 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

Active Ingredient

(in each caplet)

Acetaminophen 500mg

Purposes

Pain reliever/Fever reducer

Uses

For the temporary relief of minor aches and pains due to:

  • Headache
  • Muscular aches
  • Backache
  • Minor pain of arthritis
  • The common cold
  • Toothache
  • Premenstrual and menstrual cramps

    • Temporarily reduces fever.

Warnings

Liver warning:

This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000mg) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000mg 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

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 symptoms occur
  • redness or swelling is pressent

    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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 (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 and over:

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

      • Children under 12years: ask a doctor

Other Information

  • Do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature

Inactive Ingredients

  • Povidone
  • Pregelatinized Starch
  • Sodium Starch Glycolate
  • Stearic Acid

Questions?

If you have any questions or comments, or to report an adverse event, please contact (855) 729-7200.

Principal Display Panel

Image 1 : Extra Strength Acetaminophen 500mg, 1000ct caplets

Image 2 : Extra Strength Acetaminophen 500mg, 100ct caplets

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