Drug Facts
Active ingredient (in each caplet)
Acetaminophen USP 500 mg
Aurophen Extra Strength For Adults Tablet
FDA Label NDC 58602-755
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aurohealth Llc for the product Aurophen Extra Strength For Adults (NDC 58602-755). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- skin reddening
- blisters
- rash
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
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)
Prompt 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)
- 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
| adults and children 12 years and over | |
| children under 12 years | ask a doctor |
Other Information
- store at 20° to 25°C (68° to 77°F)
- do not use if carton is opened, or seal under cap is torn or missing.
Inactive Ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch, propylene glycol, sodium starch glycolate, talc, titanium dioxide.
Questions Or Comments?
1-855-274-4122
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
Distributed by: Aurohealth LLC.
2572 Brunswick Pike, Lawrenceville, NJ 08648
Package Label-Principal Display Panel 500 Mg (100 Caplets Bottle)
AUROHEALTH Package Label-principal Display Panel 500 mg ( 100 Caplets Bottle) (Acetaminophen Fig1)
NDC 58602-755-21
Compare to the active ingredient in Tylenol ® Extra strength Caplets*
See Warnings Information & Directions
EXTRA STRENGTH For Adults
AUROPHEN
Acetaminophen Caplets 500 mg
Pain reliever/Fever reducer
Contains No Aspirin
100 Caplets 
* Please review the disclaimer below.
