• for the temporary relief of minor aches and pains as recommended by your doctor. Because of delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. • Muscular aches. • Ask your doctor for other uses for this product.
Take with a full glass of water do not take more than directed Do not take more than 6 tablets in 24 hours Adults and children over 12 years of age Take 2 tablets every 6 hours, not more than 6 tablets in 24 hours Children under 12 years of age Ask a doctor
Acetaminophen 500 mg *Nonsteroidal antiinflammatory drug
Pain reliever/fever reducer aid
• for the temporary relief of minor aches and pains as recommended by your doctor. Because of delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief. • Muscular aches. • Ask your doctor for other uses for this product.
•
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • more than 4,000 mg of acetaminophen in 24 hours which is the maximum daily amount • 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.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
you have liver disease
if you are taking the blood thinning drug warfarin
• pain gets worse • 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.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Take with a full glass of water do not take more than directed Do not take more than 6 tablets in 24 hours
| Adults and children over 12 years of age | Take 2 tablets every 6 hours, not more than 6 tablets in 24 hours |
| Children under 12 years of age | Ask a doctor |
• store at room temperature between 20ºC - 25ºC (68ºF to 77ºF)
• Read all information before using this product. Keep this box for important information
• DO NOT USE IF CARTON IS OPENED AND/OR SAFETY SEAL IS BROKEN OR MISSING
Colloidal silicon dioxide, sodium croscarmellose, magnesium stearate, corn starch, microcrystalline cellulose
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78527-014-01 | 2024-10-07 | C162847 | 48780-1 | 1030e365-223c-111a-e063-dadaa90a10e2 | Atamel Forte |
| 78527-014-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-223c-111a-e063-dadaa90a10e2 | Atamel Forte |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 78527-014 | 78527-014-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 0d006218-648b-0b73-e063-6394a90a1075 | 2d1743de-7a56-4a06-8e31-5a330bd43bd2 | 2023-12-21 | Warnings | 2d1743de-7a56-4a06-8e31-5a330bd43bd2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.