Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: headache muscular aches the common cold minor pain of arthritis backache toothache premenstrual and menstrual cramps
Acetaminophen Tablets
- Manufacturer
- Contract Pharmacy Services-PA
- Effective date
- 2010-07-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:25:29
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 8 tablets in 24 hours do not take for more than 10 days unless directed by a doctor do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT (IN EACH TABLET)
Acetaminophen Tablets, 325mg
PURPOSE
Pain reliever/fever reducer
USES
- temporarily reduces fever
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- the common cold
- minor pain of arthritis
- backache
- toothache
- premenstrual and menstrual cramps
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 8 tablets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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: Taking more than the recommended dose (overdose) may cause liver damage. 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
adults and children 12 years and over |
|
| do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage |
OTHER INFORMATION
store at 15° to 30°C (59° to 86°F)
INACTIVE INGREDIENTS
povidone, pregelatinized starch, stearic acid
QUESTIONS OR COMMENTS?
Distributed by: Marlex Pharmaceuticals, 50 McCullough Drive, New Castle, DE 19720, U.S.A.
call toll free 1-866-820-7381
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original--08/2010--NJW
Package Label
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67046-025-30 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-dcda-621f-e053-dbdaa90a74ad | Acetaminophen Tablets |
| 67046-025-60 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-dcda-621f-e053-dbdaa90a74ad | Acetaminophen Tablets |
| 67046-025-62 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-dcda-621f-e053-dbdaa90a74ad | Acetaminophen Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67046-025-30 | Acetaminophen | 30 in 1 BLISTER PACK | TABLET | 30 | 1 | |
| 67046-025-60 | Acetaminophen | 60 in 1 BLISTER PACK | TABLET | 60 | 1 | |
| 67046-025-62 | Acetaminophen | 60 in 1 BLISTER PACK | TABLET | 60 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-123-01 | EA - Each | 10135-123 | 1c256692-0db6-4e08-aa64-8d2d3b4b2045 | 1 | 2018-11-06 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67046-025 | 67046-025-30, 67046-025-60, 67046-025-62 |
| 10135-123 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| 21cbb0e9-4d1e-4a55-bc5a-a4086ca14356 | 21cbb0e9-4d1e-4a55-bc5a-a4086ca14356 | 2010-07-30 | Warnings | 21cbb0e9-4d1e-4a55-bc5a-a4086ca14356 21cbb0e9-4d1e-4a55-bc5a-a4086ca14356 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.