Indications and uses
temporarily relieves minor aches and pains associated with ■ a headache ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
temporarily relieves minor aches and pains associated with ■ a headache ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
Adults and children 12 years of age or older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor Children under 12 years of age: Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
Acetaminophen 500 mg .....................................................................................pain reliever/fever reducer
temporarily relieves minor aches and pains associated with ■ a headache ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
Liver Warning: This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.
■ with any other product containing acetaminophen ■ for more than 10 days for pain unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor
■ symptoms do not improve ■ pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present
ask a health professional before use.
In a case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Adults and children 12 years of age or older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor
Children under 12 years of age:
Do not use this product: this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns.
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) • Avoid excessive heat and humidity
corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, and stearic acid
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71105-210-68 | 2023-01-30 | C162847 | 48780-1 | f386c649-b0fc-0266-e053-dadaa90a7c1a | Acetaminophen (non-aspirin) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71105-210-68 | Non-Aspirin Acetaminophen | 100 in 1 CARTON | TABLET | 100 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71105-210 | 71105-210-68 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| SODIUM STARCH GLYCOLATE TYPE A CORN | AG9B65PV6B | IACT |
| STEARIC ACID | 4ELV7Z65AP | 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 |
|---|---|---|---|---|---|---|
| c62a04fc-6870-112d-e053-2a95a90ae61e | 47e01739-bff3-51ef-e054-00144ff88e88 | 2021-07-02 | Warnings | c62a04fc-6870-112d-e053-2a95a90ae61e 47e01739-bff3-51ef-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.