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
- Manufacturer
- Marlex Pharmaceuticals Inc
- Effective date
- 2026-02-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:36:48
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections
Dosage and administration
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 6 tablets 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.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
(in each tablet)
Acetaminophen USP 500 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 6 tablets (3,000 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.
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 overdosewarning)
Adults and Children 12 years and over:
- Take 2 tablets every 6 hours while symptoms last.
- Do not take more than 6 tablets 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.
Other Information
- Store between 20-25 ˚C (68-77 ˚F).
Inactive Ingredients
Pregelatinized Starch, Povidone K 30,Sodium starch Glycolate, Stearic Acid.
Manufactured for/ Distributed by:
Marlex Pharmaceuticals, Inc.
New Castle, DE 19720
Rev. 01/26 AA
Principal Display Panel
ACETAMINOPHEN
500 MG
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-829-01 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-829-01 | EA - Each | 10135-829 | 03760ab6-edac-49f4-8094-88affe7deb2d | 1 | 2026-03-17 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POVIDONE K30
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STARCH, CORN
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10135-829 | 10135-829-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 | Marlex Pharmaceuticals Inc | 4a183b7d-3a1e-5557-e063-6294a90a5493 | 2026-02-01 | Warnings | 10135-829-01 10135-829 10135082901 4a183bb4-ec85-c7d2-e063-6394a90ad356 4a183b7d-3a1e-5557-e063-6294a90a5493 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.