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
Acetaminophen
- Manufacturer
- Aurohealth LLC | APL HEALTHCARE LIMITED
- Effective date
- 2023-11-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:02:55
Label at a glance#
ProductAcetaminophen
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 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 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 (100 Caplets Bottle)
AUROHEALTH
NDC 58602-773-21
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
100 Caplets
500 mg each
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-773-21 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 58602-773-21 | EA - Each | 58602-773 | 529c6518-8457-4be5-86a6-7016e33ade7e | 1 | 2022-05-04 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POVIDONE K30
- STARCH, CORN
- PALMITOSTEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-773 | 58602-773-21 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K30 | U725QWY32X | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| PALMITOSTEARIC ACID | Q8Y7S3B85M | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Aurohealth LLC | a4ff94b9-c248-4cd3-8491-38e9555cc22e | 2023-11-29 | Warnings | 58602-773-21 58602-773 58602077321 0b458b7d-7add-0991-e063-6294a90a697d a4ff94b9-c248-4cd3-8491-38e9555cc22e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.