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US · Over-the-counter medicine

Pain ReliefExtra Strength

Dosage form
CAPSULE, COATED
Labeler
Allegiant Health
Label updated
2021-05-17
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
Active ingredient(s)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Use(s)

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 4,000mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical 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 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 present. These could be signs of a serious
    condition

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 8 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
Storage

store between 20º-25ºC (68º-77ºF)

Inactive ingredients

corn starch*, hypromellose, polyethylene glycol, povidone, pregelatinized starch,
purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
*may contain these ingredients

Questions

Call 1-888-952-0050 Monday to Friday 9am-5pm EST

Principal Display Panel

[Image in the official label — see DailyMed source]


DailyMed Set ID: 0f72be92-fac0-4be4-87a3-3f20f0f01db5 · Version 7
NDC: 69168-426