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US · Over-the-counter medicine

Pain Relief Extra Strength

Dosage form
TABLET, COATED
Labeler
TOPCO ASSOCIATES LLC
Label updated
2021-03-08
Retrieved
2026-09-07
Active ingredients
Acetaminophen
View original label and images on DailyMed ↗
Label information

Drug Facts

Active ingredient (in each caplet)

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 8 caplet in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Label information

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

Label information

Ask a doctor before use if you have liver disease

Label information

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.

Label information

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

Label information

Keep out of reach of children.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away.

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 use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor
Other information
  • store between 20-25°C (68-77°F)
Inactive ingredients

crosscarmellose sodium, lactose monohydrate, magnesium stearate, polethylene glycol, polyvinyl alcohol, povidone, purified water, sodium starch glycolate, starch corn, talc, titanium dioxide

Questions?

call 1-888-577-8033

PRINCIPAL DISPLAY PANEL - 200 Caplet Bottle Label

NDC 36800-150-20

Compare to the active ingredient
in Tylenol® Extra Strength

EXTRA STRENGTH

Pain
Relief

ACETAMINOPHEN 500 mg
PAIN RELIEVER
FEVER REDUCER

200
CAPLETS

[Image in the official label — see DailyMed source]

DailyMed Set ID: d9bce324-6869-40cd-8f38-d405d8686475 · Version 1
NDC: 36800-961