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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 gelcap)

Acetaminophen USP 500 mg

Purpose

Pain reliever/fever reducer

Uses
  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • 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 gelcaps every 6 hours while symptoms last
  • do not take more than 6 gelcaps 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). Avoid high humidity
  • do not use if carton is open. Do not use if printed foil seal under cap is torn or missing
Inactive ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, FD&C blue #1, FD&C red #3, FD&C red #40, gelatin, hydroxypropyl cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch (maize), propylene glycol, shellac glaze, sodium starch glycolate, talc and titanium dioxide.

Questions or comments?

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 (100 Gelcaps Container Label)

AUROHEALTH
NDC 58602-745-21
FOR ADULTS
EXTRA STRENGTH
Acetaminophen Gelcaps 500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels
100 GELCAPS
500 mg each



[Image in the official label — see DailyMed source]


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 500 mg (100 Gelcaps Container Carton)

AUROHEALTH
Compare to the active ingredient in
Extra Strength Tylenol ®Rapid Release Gels
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
NDC 58602-745-21
FOR ADULTS

EXTRA STRENGTH
Acetaminophen
Gelcaps 500 mg
Pain Reliever, Fever Reducer
Rapid Release Gels

Actual Size
100 GELCAPS

500 mg each



[Image in the official label — see DailyMed source]

DailyMed Set ID: bc03fa56-8880-4bbd-81a0-91853fecdd4e · Version 2
NDC: 58602-745