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
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
■ 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 take 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 take more than 5 days unless d...
(in each tablet)
Acetaminophen, USP 325 mg
Pain Reliever/ Fever reducer
■ headache
■ muscular aches
■ backache
■ minor pain of arthritis
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
temporarily reduces fever
This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. 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, which is the maximum daily amount
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks every day while using this product
■ 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 other inactive ingredients in this product
you have liver disease
the user is taking the blood thinning drug warfarin
■ pain gets worse or lasts more than 10 days in adults
■ pain gets worse or lasts more than 5 days in children under 12 years
■ 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 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.
■ 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 take 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 take more than 5 days unless directed by a doctor
children under 6 years
ask a doctor
■ store between 20-25°C (68-77°F).
■ do not use if carton is opened or neck wrap or foil inner seal imprinted is broken or missing
hydroxy propyl cellulose, polyethylene glycol, povidone k-30, pregelatinized starch, purified water, sodium starch glycolate, stearic acid
call 1-844-724-7347 Mon-Fri 9:00 AM to 4:30 PM EST
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-655-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-fedb-f424-e053-dadaa90a57ce | Acetaminophen Tablets, USP 325 mg |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-655-10 | Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68016-655 | 68016-655-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, PREGELATINIZED CORN | O8232NY3SJ | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| HYDROXYPROPYL CELLULOSE, UNSPECIFIED | 9XZ8H6N6OH | IACT |
| POLYETHYLENE GLYCOLS | 3WJQ0SDW1A | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | 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 |
|---|---|---|---|---|---|---|
| 4c085750-812a-6716-e054-00144ff8d46c | 3e0af4be-635e-71da-e054-00144ff88e88 | 2017-03-31 | Warnings | 4c085750-812a-6716-e054-00144ff8d46c 3e0af4be-635e-71da-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.