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
- Manufacturer
- Unit Dose Services
- Effective date
- 2019-03-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:58:58
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 4 to 6 hours while symptoms last • do not take more than 10 tablets in 24 hours • 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 • do not use for more than 5 days un...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Acetaminophen 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. 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
- 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 the user has ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if the user
- has liver disease
- is a child with pain of arthritis
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 (for adults) or 5 days (for children)
- 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 6-11 years |
| |
children under 6 years | ask a doctor |
Inactive ingredients
croscarmellose sodium*, povidone, pregelatinized starch, stearic acid
*may contain this ingredient
Questions or comments?
1-800-616-2471
HOW SUPPLIED
Product: 50436-6719
NDC: 50436-6719-1 24 TABLET in a BOTTLE
ACETAMINOPHEN TABLET
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-6719-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-39f9-a910-e053-dadaa90a0b85 | Major Pharmaceuticals Acetaminophen Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-6719-1 | Acetaminophen | 24 in 1 BOTTLE | TABLET | 24 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-6719 | ACETAMINOPHEN TABLET [UNIT DOSE SERVICES] | 2 | Legacy NDC, 1 package rows | 20190326_367c158f-c397-4822-8fe4-4281fb58c71b.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6719-50 | EA - Each | 0904-6719 | 1475eb1d-0b4d-4470-9985-1f4f8a6c9de5 | 1 | 2018-12-13 |
| 0904-6719-60 | EA - Each | 0904-6719 | 6ad17407-abca-48c5-8fc1-b25e9ff15d40 | 1 | 2018-12-13 |
| 0904-6719-80 | EA - Each | 0904-6719 | 3949a6d6-57bb-4d85-bf8c-da4e1f71dd1c | 1 | 2019-02-13 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- CROSCARMELLOSE SODIUM
- POVIDONE, UNSPECIFIED
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50436-6719 | 50436-6719-1 |
| 0904-6719 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| 8fdd89de-35a3-4187-b5b6-a02452ce4dc7 | 367c158f-c397-4822-8fe4-4281fb58c71b | 2019-03-25 | Warnings | 8fdd89de-35a3-4187-b5b6-a02452ce4dc7 367c158f-c397-4822-8fe4-4281fb58c71b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.