Otc - Active Ingredient
Aspirin 81mg (NSAID)
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Aspirin 81mg (NDC 70692-126). 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 otc - active ingredient, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81mg (NSAID)
anhydrous lactose*, carnuba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, D&C yellow #6*, hydroxy propyl methyl cellulose, iron oxide*, isopropyl alcohol, magnesium stearate*, methacrylic acid copolymer type c, microcrystalline cellulose, polythylene glycol, polysorbate 80*, pregelatinized starch, silicon dioxide, sodium hydroxide*, sodium lauryl sulfate, stearic acid*, talc, titanium dioxide, triethyl citrate. *may contain.
* drink a full glass of water with each dose SEE OVERDOSE WARNING.
| adults and children 12 years of age 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 of age | ask a doctor |
* 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.
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
Do not use
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are taking a prescription drug for
Stop use and ask a doctor if
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.
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.
Keep out of reach of children.
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.
Pain reliever
* store at room temperature 20 - 25°C (68 - 77°F).
* avoid excessive heat, cold and humidity.
* close cap tightly after use.
* Please review the disclaimer below.