Indications and uses
For the temporary relief of aches and pains due to: headache, colds, menstrual pain, muscle pain, toothache, minor pain of arthritis or as directed by your doctor
For the temporary relief of aches and pains due to: headache, colds, menstrual pain, muscle pain, toothache, minor pain of arthritis or as directed by your doctor
Drink a full glass of water with each dose Adults and children 12 years and over: TAKE 1 TO 2 TABLETS EVERY 4 HOURS WHILE SYMPTOMS LAST. DO NOT TAKE MORE THAN 12 TABLETS IN 24 HOURS, UNLESS DIRECTED BY A DOCTOR. Children under 12 years: CONSULT A DOCTOR.
Each tablet contains Aspirin 325 mg (NSAID)
Corn Starch, Croscarmellose Sodium, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Titanium Dioxide
Pain Reliever
Drink a full glass of water with each dose
Adults and children 12 years and over: TAKE 1 TO 2 TABLETS EVERY 4 HOURS WHILE SYMPTOMS LAST. DO NOT TAKE MORE THAN 12 TABLETS IN 24 HOURS, UNLESS DIRECTED BY A DOCTOR.
Children under 12 years: CONSULT A DOCTOR.
For the temporary relief of aches and pains due to:
headache, colds, menstrual pain, muscle pain, toothache, minor pain of arthritis or as directed by your doctor
Reyes'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 hives, facial swelling, shock, asthma (wheezing)
Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others): have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.
Do not use if you are allergic to aspirin or any other pain reliever/fever reducer
Ask a doctor before use if • stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease • you are taking a diuretic • you have asthma • you have not been drinking fluids • you have lost a lot of fluid due to vomiting or diarrhea
As a doctor or pharmacist if you are taking a prescription drug for diabetes, gout or arthritis; taking any other drug; under a doctor’s care for any serious condition
Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: feel faint, have bloody or black stools, vomit blood, have stomach pain that does not get better • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms occur • ringing in the ears or a loss of hearing occurs.
If pregnant or breast feeding, 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.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-011-01 | EA - Each | 49483-011 | 1a8b4a59-e054-44a3-8315-d49574cf89e3 | 1 | 2012-07-24 |
| 49483-011-10 | EA - Each | 49483-011 | d996d20c-42cd-41a2-a29a-679d7f395c76 | 1 | 2014-05-02 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 48433-305 | 48433-305-01, 48433-305-10 |
| 49483-011 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ASPIRIN | R16CO5Y76E | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| CROSCARMELLOSE SODIUM | M28OL1HH48 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, COATED / ORAL | 920 mg | ||
| HYPROMELLOSES | HYPROMELLOSE | 3NXW29V3WO | TABLET, COATED / ORAL | 58 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, COATED / ORAL | 224 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg |
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 |
|---|---|---|---|---|---|---|
| ASPIRIN | ASPIRIN | TIME CAP LABS INC | fe12519c-3e5f-4592-bd34-2d6b81b981f4 | 2023-11-22 | Warnings | 49483-011 |
| 5b102236-e994-4286-ba38-deb16b325228 | 5b102236-e994-4286-ba38-deb16b325228 | 2014-04-02 | Warnings | 5b102236-e994-4286-ba38-deb16b325228 5b102236-e994-4286-ba38-deb16b325228 |
Adverse event summaries are temporarily unavailable. Other product information remains available.