Active Ingredient (In Each Tablet)
Aspirin 81mg (NSAID)*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Aspirin Pain Reliver (NDC 72090-034). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses:, warnings:, stop use and ask a doctor if, pregnancy, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81mg (NSAID)*nonsteroidal anti-inflammatory drug
Pain reliever
• for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief
• ask your doctor about other uses for Safety Coated 81 mg Aspirin
Reye's syndrome
Children and teenagers who have or are recovering from chickenpox 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:
Do not use
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 (1-800-222-1222) right away.
• store at room temperature. Avoid excessive heat above 40°C (104°F).
Microcrystalline Cellulose, Lactose, Croscarmellose Sodium, Colloidal Silicon Dioxide, Acrycoat L30D (Methacrylic acid copolymer), Triethyl citrate, Polysorbate 80, Sodium hydroxide, Talc, Titanium Dioxide, D & C yellow # 10 Aluminum lake, Yellow oxide of iron.
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