Indications and uses
■ temporarily 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
- SAM'S WEST INC
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 01:27:05
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure16 sections
Dosage and administration
■ do not take more than directed (see overdose warning) adults and children ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor 12 years and over children under 12 years ■ ask a doctor
Storage and handling
■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature. ■ see bottom of the label for lot number and expiration date
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each caplet)
Acetaminophen USP, 500 mg
Purpose
Pain reliever/fever reducer
Uses
■ temporarily 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. 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
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
Ask a doctor before use if you have
liver disease
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 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
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 ■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
12 years and over
children under 12 years ■ ask a doctor
Other information
■ store between 20-25°C (68-77°F). See USP Controlled Room Temperature.
■ see bottom of the label for lot number and expiration date
Inactive ingredients
hydroxypropyl methyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid
Questions or comments?
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PDP
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68196-177-61 | Acetaminophen | 600 in 1 BOTTLE | TABLET | 600 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68196-177-61 | EA - Each | 68196-177 | 4d4ff6de-d165-4ad5-abb3-6b9482d54a4b | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- POVIDONE
- STEARIC ACID
- POLYETHYLENE GLYCOL, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STARCH, CORN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68196-177 | 68196-177-61 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | 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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | SAM'S WEST INC | 0c8e7095-0806-4501-e063-6394a90a89aa | 2025-12-19 | Warnings | 68196-177-61 68196-177 68196017761 46538673-56ff-e1fd-e063-6394a90a5052 0c8e7095-0806-4501-e063-6394a90a89aa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.