Otc - Active Ingredient
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)#
#nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Aspirin 81 (NDC 57237-302). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each tablet)
Aspirin 81 mg (NSAID)#
#nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
• temporarily relieves minor aches and pains
• ask your doctor about other uses for enteric coated 81 mg Aspirin.
Warnings
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:
•hives • facial swelling • asthma (wheezing) • shock
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 nonprescription 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
Ask a doctor before use if
Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes or arthritis
Stop use and ask a doctor if
●feel faint ● vomit blood ● have bloody or black stools ● have stomach pain that does not get better
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.
Directions
Other information
Inactive ingredients
colloidal silicon dioxide, crosscarmellose sodium, D&C yellow#10, FD&C yellow#6, methacrylic acid copolymer, microcrystalline cellulose, silicon dioxide, stearic acid, talcum, titanium dioxide, triethyl citrate
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