Indications and uses
Temporary 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 325mg
- Manufacturer
- Marlex Pharmaceuticals Inc
- Effective date
- 2021-02-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:47
Label at a glance#
ProductAcetaminophen 325mg
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
Do not take m ore than directed (see overdose warning ) Adults and Children 12 years and over: Take 2 tablets every 6 hours while symptoms last. Do not take more than 12 tablets in 24 hours, unless directed by a doctor. Do not use for more than 10 days unless directed by a doctor. Children 6-11 years: Take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablets in 24 hours. Children under ...
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient (in each tablet)
Acetaminophen USP 325 mg
Purpose
Pain Reliever/ Fever Reducer
Uses
Temporary 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. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours. 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
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.
Drug Facts (continued)
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
Do not take more than directed (see overdose warning)
Adults and Children 12 years and over:
- Take 2 tablets every 6 hours while symptoms last.
- Do not take more than 12 tablets in 24 hours, unless directed by a doctor.
- Do not use for more than 10 days unless directed by a doctor.
Children 6-11 years:
- Take 1 tablet every 4 to 6 hours while symptoms last.
- Do not take more than 5 tablets in 24 hours.
Children under 6 years:
- ask a doctor.
Other Information
- Store between 20-25
˚C (68-77
˚F).
- See end panel for lot number and expiration date.
Inactive Ingredients
Povidone, Pregelatinized Starch, Sodium Carboxymethyl Starch, Stearic Acid
Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
PRINCIPAL DISPLAY PANEL
NDC 10135-0123-01
Acetaminophen
325 mg
100 TABLETS
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10135-123-01 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-5d3f-a910-e053-dadaa90a0b85 | Acetaminophen 325mg |
| 10135-123-01 | 2021-02-04 | C162847 | 48780-1 | ba0f9c33-5d3f-a910-e053-dadaa90a0b85 | Acetaminophen 325mg |
| 10135-123-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5d3f-a910-e053-dadaa90a0b85 | Acetaminophen 325mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-123-01 | Acetaminophen 325mg | 100 in 1 BOTTLE | TABLET | 100 | 3 |
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 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen 325mg
- Acetaminophen
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- STEARIC ACID
- POVIDONE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10135-123 | 10135-123-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
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 |
|---|---|---|---|---|---|---|
| ba72bba7-176e-4f83-e053-2995a90a86ec | c26f1872-ebff-4164-bf64-4272df43a2db | 2021-02-03 | Warnings | ba72bba7-176e-4f83-e053-2995a90a86ec c26f1872-ebff-4164-bf64-4272df43a2db |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.