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Acetaminophen

Dosage form
TABLET, COATED
Labeler
Bonita Pharmaceuticals LLC
Label updated
2013-04-02
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
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.

Label information

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 12 years: 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 in the official label — see DailyMed source]

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

[Image in the official label — see DailyMed source]

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

DailyMed Set ID: 9a4c1908-93dc-4f73-aea6-d24cb862938a · Version 1
NDC: 53598-003