Otc - Active Ingredient
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Drug Facts
Active ingredient (in each tablet) Purpose
Aspirin 81 mg (NSAID*). . . . . . . . . . . . . . . . . . .Pain reliever
*nonsteroidal anti-inflammatory drug
Aspirin Tablet
FDA Label NDC 49483-390
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time-cap Labs, Inc for the product Aspirin (NDC 49483-390). 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, otc - ask doctor, otc - ask doctor/pharmacist, otc - pregnancy or breast feeding, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses • temporarily relieves minor aches and pains• for other uses, see your doctor, but do not use for morethan 10 days without consulting your doctor becauseserious side effects may occur
Otc - Ask Doctor
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
Ask a doctor or pharmacist before use if you are
• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug
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
Ask a doctor or pharmacist before use if you are
• taking a prescription drug for diabetes, gout, or arthritis
• under a doctor’s care for any serious condition
• taking any other drug
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are• taking a prescription drug for diabetes, gout, or arthritis• under a doctor’s care for any serious condition• taking any other drug
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional beforeuse. It is especially important not to use aspirin during the last3 months of pregnancy unless definitely directed to do so by adoctor because it may cause problems in the unborn child orcomplications during delivery.Keep out of reach of children. In case of overdose, get medicalhelp or contact a Poison Control Center right away.
Package Label.Principal Display Panel
Image Of Bulk Label (390bulk)
* Please review the disclaimer below.
