Acetaminophen Extra Strength
- Dosage form
- TABLET
- Labeler
- Aurohealth LLC
- Label updated
- 2023-11-29
- Retrieved
- 2026-09-07
- Active ingredients
- ACETAMINOPHEN
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
|
|
| 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