Indications and uses
Uses • temporarily relieves minor aches and pains
Uses • temporarily relieves minor aches and pains
Directions • 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.
• store at 25° (77°C) excursions permitted between 15°-30°
Active Ingredient (in each tablet)
Aspirin 81 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Pain reliever
Uses
Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
Ask a doctor before use if
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:
Directions
Ask a doctor before use if
Ask a doctor if
These could be signs of a serious condition.
Inactive Ingredients anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate
Other Information
July 2019
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63739-212-01 | EA - Each | 63739-212 | 0d5e56f1-2f7c-4c97-9d6b-cc04bf6224ca | 1 | 2020-03-10 |
| 63739-212-02 | EA - Each | 63739-212 | 2280cbd1-9174-4646-9859-54ec0b1c5065 | 1 | 2021-06-02 |
| 63739-212-10 | EA - Each | 63739-212 | 1ec12e06-3c5c-4c71-91e8-c372d043f266 | 1 | 2020-03-10 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55154-8146 | 55154-8146-0 |
| 63739-212 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 7c71822f-c5d0-405d-af11-ce1badb1cc82 | 6fbfea14-cd6e-4ead-a77f-04fed8f944f7 | 2022-02-23 | Warnings | 6fbfea14-cd6e-4ead-a77f-04fed8f944f7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.