OTC - ACTIVE INGREDIENT SECTION
Active Ingredient/Tablet Aspirin 325 mg
Active Ingredient/Tablet Aspirin 325 mg
Purpose-Pain Reliever/Fever Reducer
Temporarily relieves pain due to: headache, muscular aches, cold, minor pain of arthritis. Temporarily reduces fever
Adults: Take 2 tablets every 4hours, not to exceed 12 caplets in 24 hours
Children under 12 years, ask a doctor
Warnings:
Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Stomach Bleeding Warning:This product contains nonsteroidal anti-inflammatory dugs (NSAIDs), which may cause 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 an NSAID (aspirin, ibuprofen, naproxen, or others.
• Take more or for a longer time than directed
Allergy Alert-Do not use:
• if you are allergic to aspirin or any other salicylates
• If you have ever had an allergic reaction to any other pain reliever/fever reducer
Do not use:
• with any other pain reliever/fever reducer
Ask doctor before using if you have:
• upset stomach or stomach pain
• ulcers
• bleeding problems
• high blood pressure
• heart or kidney disease
• taken a diuretic
• reached age 60 or older
Ask a doctor or pharmacist before use if you are:
• taking any other drug containing an NSAID (prescription or nonprescription)
• taking a blood thinning (anticoagulant) or steroid drug
Stop use and ask a doctor if:
• ringing in the ears or loss of hearing occurs
• pain or fever persists or gets worse
• new symptoms occur
• redness or swelling is present
• you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding
If pregnant or breast-feeding baby, ask a health professional
before use
KEEP OUT OF REACH OF CHILDREN. In 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.
Inactive Ingredients: corn starch, microcrystalline cellulose,
povidone,
MM
1
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42961-044 | 42961-044-01, 42961-044-02, 42961-044-03, 42961-044-04 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| POVIDONE K29/32 | 390RMW2PEQ | IACT |
| ASPIRIN | R16CO5Y76E | 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 |
|---|---|---|---|---|---|---|
| db9ab367-1121-4e8d-8231-e69c0a1be6ae | 4c30be81-fa96-4038-80df-a9a02ccf2d5b | 2022-12-27 | Warnings | 4c30be81-fa96-4038-80df-a9a02ccf2d5b |
Adverse event summaries are temporarily unavailable. Other product information remains available.