Indications and uses
temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
temporarily relieves minor aches and pains for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur
drink a full glass of water with each dose adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor children under 12 years: consult a doctor
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever
• feel faint
• have bloody or black stools
• vomit blood
• have stomach pain that does not get better
• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug
• under a doctor’s care for any serious condition
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact Poison Control Center right away
BHT, dextrates, FD&C yellow #6 aluminum lake, microcrystalline cellulose, modified corn starch, orange flavor, pregelatinized starch, sodium saccharin, stearic acid
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Dr.,Suite 233
Livonia, MI 48152 USA
M-14
L700313.01 Rev. 03/17
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6288-80 | EA - Each | 0904-6288 | 6764713c-a888-4e9e-8a26-cee1e735d28e | 1 | 2017-11-06 |
| 0904-6288-89 | EA - Each | 0904-6288 | ed0a1686-0d72-4f58-aa21-42429910a983 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0615-7863 | 0615-7863-39 |
| 0904-6288 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | IACT |
| DEXTRATES | G263MI44RU | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) | 461P5CJN6T | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ORANGE | 5EVU04N5QU | 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 |
|---|---|---|---|---|---|---|
| e36d556a-b5a0-4b12-bacd-8ca2c22bd96e | a22b8f8d-90d4-4f3b-8f2e-eeddc7f203ad | 2018-08-09 | Warnings | e36d556a-b5a0-4b12-bacd-8ca2c22bd96e a22b8f8d-90d4-4f3b-8f2e-eeddc7f203ad |
Adverse event summaries are temporarily unavailable. Other product information remains available.