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Acetaminophen Extra Strength

Dosage form
TABLET
Labeler
Aurohealth LLC
Label updated
2023-11-29
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
Drug Facts

Active ingredient (in each caplet)

Acetaminophen USP 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
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.

If pregnant or breast-feeding,

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 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
  • store between 20° to 25°C (68° to 77°F)
  • do not use if printed foil seal under cap is torn or missing.
Inactive ingredients

povidone, pregelatinized starch (maize), stearic acid.

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC.
279 Princeton- Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (750 Caplets Bottle)

NDC 58602-776-88Primary Health

Compare to the active ingredient in
Tylenol ® Extra strength Caplets *
 

See New Warnings Information & Directions

EXTRA STRENGTH
For Adults
Pain Relief
Acetaminophen Caplets 500 mg
Pain reliever/Fever reducer
N 79

750 CAPLETS
500 mg each

[Image in the official label — see DailyMed source]


DailyMed Set ID: 57bb1acc-b9a0-48cd-8e5c-33712441ce81 · Version 2
NDC: 58602-776