Indications and 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
Acetaminophen Regular Strength
- 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 Regular Strength
Active ingredientACETAMINOPHEN
Label structure16 sections
Dosage and administration
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do...
Storage and handling
store between 20° to 25°C (68° to 77°F) do not use if carton is open or 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 tablet)
Acetaminophen USP 325 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 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 the user has
liver disease
Ask a doctor or pharmacist before use if the user is
taking the blood thinning drug warfarin
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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 6 years to under 12 years
|
|
| children under 6 years
| ask a doctor
|
Other information
- store between 20° to 25°C (68° to 77°F)
- do not use if carton is open or if printed foil seal under cap is torn or missing.
Inactive ingredients
povidone, pregelatinized starch (maize), stearic acid.
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 325 mg (100 Tablets Bottle)
AUROHEALTH
NDC 58602-775-21
REGULAR STRENGTH
Pain Relief
Acetaminophen
Tablets 325 mg
Pain Reliever/
Fever Reducer
100
Tablets
325 mg each
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 325 mg (100 Tablets Bottle Carton)
AUROHEALTH
NDC 58602-775-21
Compare to the active ingredient in
Tylenol
®Regular Strength tablets
*
RREGULAR STRENGTH
Acetaminophen
Tablets 325 mg
Pain Reliever/Fever Reducer
DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN
Actual size
100
Tablets
325 mg each
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58602-775-21 | Acetaminophen Regular Strength | 1 in 1 CARTON | TABLET | 1 | 2 | |
| 58602-775-21 | Acetaminophen Regular Strength | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Acetaminophen Regular Strength
- Acetaminophen
- POVIDONE K30
- STARCH, CORN
- PALMITOSTEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58602-775 | 58602-775-21 |
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 Regular Strength | ACETAMINOPHEN | Aurohealth LLC | cc0ab7a1-e535-4dc8-962f-c58949fc1737 | 2023-11-29 | Warnings | 58602-775-21 58602-775 58602077521 0b4563cf-6c4a-fcd5-e063-6294a90ae597 cc0ab7a1-e535-4dc8-962f-c58949fc1737 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.