Indications and 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
Aurophen Extra Strength for Adults
- Manufacturer
- Aurohealth LLC | APL HEALTHCARE LIMITED
- Effective date
- 2023-11-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:56
Label at a glance#
ProductAurophen Extra Strength for Adults
Active ingredientACETAMINOPHEN
Label structure15 sections
Dosage and administration
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
Storage and handling
store between 20° to 25°C (68° to 77°F) do not use if carton is opened, or printed foil seal under cap is torn or missing.
Contacts and useful links#
Label contents#
Full prescribing information#
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
|
|
| children under 12 years
| ask a doctor
|
Other information
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is opened, or printed foil seal under cap is torn or missing.
Inactive ingredients
colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, pregelatinized starch (starch), propylene glycol, sodium starch glycolate, talc, titanium dioxide.
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 (600 Caplets Bottle)
Healthy Living
™
See New Warnings Information & Directions
Extra Strength
For Adults
PAIN RELIEF
acetaminophen caplets 500 mg
Pain Reliever/Fever Reducer
*Compare
to the Active
Ingredient in
Tylenol
®Extra
Strength
Caplets
600 Caplets
500 mg each
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-771-36 | Aurophen Extra Strength for Adults | 250 in 1 BOTTLE | TABLET | 250 | 3 | |
| 58602-771-40 | Aurophen Extra Strength for Adults | 500 in 1 BOTTLE | TABLET | 500 | 3 | |
| 58602-771-41 | Aurophen Extra Strength for Adults | 1000 in 1 BOTTLE | TABLET | 1000 | 3 | |
| 58602-771-64 | Aurophen Extra Strength for Adults | 600 in 1 BOTTLE | TABLET | 600 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Aurophen Extra Strength for Adults
- Acetaminophen
- SILICON DIOXIDE
- HYDROXYPROPYL CELLULOSE (1600000 WAMW)
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- STARCH, CORN
- PROPYLENE GLYCOL
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-771 | 58602-771-36, 58602-771-40, 58602-771-41, 58602-771-64 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Aurophen Extra Strength for Adults | ACETAMINOPHEN | Aurohealth LLC | d59c5f04-4bcc-4a52-a42f-e049506f00de | 2023-11-29 | Warnings | 58602-771-36 58602-771-64 58602-771-40 58602-771-41 58602-771 58602077141 58602077164 58602077136 58602077140 0b45ad4e-d9d9-d463-e063-6294a90a195d d59c5f04-4bcc-4a52-a42f-e049506f00de |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.