Otc - Active Ingredient
Aspirin 81 mg (NSAID)*
The following Structured Product Label (SPL) was submitted to the FDA by Wisdrug Ag for the product Wispirin (NDC 87580-001). 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, warnings, dosage & administration, storage and handling, inactive ingredient, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Aspirin 81 mg (NSAID)*
Pain reliever / fever reducer
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
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 if you are allergic to aspirin or any other pain reliever/fever reducer.
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if the 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
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
• anticoagulation (thinning of the blood)
• gout
• diabetes
• arthritis
Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away.
Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:
• feel faint
• vomit blood
• have bloody or black stools
• have stomach pain that does not get better
• pain gets worse or lasts more than 10 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or loss of hearing occurs
You may report side effects to FDA at 1-800-FDA-1088.
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 specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
• drink a full glass of water with each dose
• before use, disperse the tablet in water immediately and take the suspension promptly, or swallow the tablet whole with water
• do not chew, crush, or split
• adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist; do not exceed 48 tablets in 24 hours unless directed by a doctor
• children under 12 years of age: ask a doctor
• store at 20-25°C (68-77°F)
• protect from moisture
• do not use if imprinted safety seal under cap is broken or missing
Hypromellose, Talc, Hypromellose acetate succinate, Hypromellose phthalate, Triethyl citrate, Microcrystalline cellulose, Povidone K30, Crospovidone, Stearic acid, Aspartame, Anhydrous citric acid, Copovidone,Polysorbate 80,Methacrylic acid - ethyl acrylate copolymer,Glyceryl monostearate.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• temporrily relieves minor aches and pains
• reduces fever
• for adults who have had a heart attack orstroke:helpspreventanother heart attack or stroke (under a doctor's supervision)
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 this product.
* Please review the disclaimer below.