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US · Over-the-counter medicine

Pain ReliefExtra Strength

Dosage form
TABLET
Labeler
Allegiant Health
Label updated
2021-11-23
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
Active ingredient(s)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Use(s)

temporary relief of minor aches and pains associated with   ■ common cold   ■ headache    ■  toothache 

■ muscular aches  ■ backache     ■ arthritis    ■ menstrual cramps    ■ and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount 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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children


In case of overdose, get medical help or contact a Poison Control Center 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 use 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 use more than 10 days unless directed by a doctor  

children under 12 years: ask a doctor 

Other information
  • store between 20º-25ºC (68º-77ºF)

  • do not use if imprinted safety seal under cap is broken or missing
  • You may report side effects to 1-888-952-0050
Inactive ingredients

corn starch, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]


DailyMed Set ID: d41d2319-8eed-4df9-813c-313497ceb8b4 · Version 3
NDC: 69168-005