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
■ 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
■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ 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 children under 12 years ask a doctor
(in each Caplet)
Acetaminophen, USP 500 mg
Pain reliever/fever reducer
■ 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
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
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.
■ 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
liver disease
taking the blood thinning drug warfarin
■ 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.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Promt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ do not take more than directed (see overdose warning)
adults and children 12 years and over
■ 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
children under 12 years
ask a doctor
■ store between 20-25°C (68-77°F).See USP Controlled Room Temperature
■ avoid high humidity
■ see end panel for lot number and expiration date
hydroxypropyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST.
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69848-003-10 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 8 | |
| 69848-003-17 | Acetaminophen | 175 in 1 BOTTLE | TABLET | 175 | 8 | |
| 69848-003-24 | Acetaminophen | 24 in 1 BOTTLE | TABLET | 24 | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69848-003 | 69848-003-24, 69848-003-10, 69848-003-17 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
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 | Granules USA, Inc | a1255f60-b9c6-9a95-e053-2995a90a9e80 | 2025-12-22 | Warnings | 69848-003-10 69848-003-24 69848-003-17 69848-003 69848000317 69848000324 69848000310 468e5f4e-8bc6-6b97-e063-6294a90a0166 a1255f60-b9c6-9a95-e053-2995a90a9e80 |
Adverse event summaries are temporarily unavailable. Other product information remains available.