Active Ingredient
Aspirin 81mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Low Dose Aspirin Tablet, Coated
FDA Label NDC 71205-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Low Dose Aspirin (NDC 71205-112). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Pain Reliever
Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose get medical help or contact a poison control center right away.
Uses
Temporarily relieves minor aches and pains
For other uses, see your doctor but do not use for more than 10 days without consulting your doctor because serious side effects may occur
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, shock, asthma(wheezing).
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 bleeding problems
Take a blood thinning (anticoagulant) or steroid drug
Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
Directions
Drink a full glass of water with each dose
Adults and children of 12 years and over, take 4-8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
Children under 12 years: consult a doctor
Inactive Ingredients
Anhydrous lactose, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, simethicone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.
* Please review the disclaimer below.
