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EXTRA STRENGTH ACETAMINOPHEN

Dosage form
TABLET
Labeler
Spirit Pharmaceutical LLC
Label updated
2024-12-20
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 4,000 mg 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

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. (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 use for more than 10 days unless directed by a doctor
children under 12 years ask a doctor
Other information
  • each caplet contains: magnesium 0.43 mg
  • store between 20-25°C (68-77°F)
  • do not use if carton is opened or inner Safety Seal is broken or missing
Inactive ingredients

Hypermellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinylpyrrolidone, pregelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

1-855-736-3346

PRINCIPAL DISPLAY PANEL

COMPARE TO EXTRA STRENGTH TYLENOL® ACTIVE INGREDIENT*

Dr. Juan's 

Santo Remedio

PARA EL

DOLOR

Para el Dolor / Bajar La Fiebre
No Contiene Aspirina

Acetaminofén Extra Fuerte

Acetaminophen Extra Strength
Pain Reliever / Fever Reducer / Contains No Aspirin

500 MG · 100 CAPLETAS/CAPLETS

[Image in the official label — see DailyMed source]

DailyMed Set ID: dca3f1b7-004f-4972-95dc-efeacfb4cb32 · Version 6
NDC: 68210-6113