FDA Label for Medpurine
View Indications, Usage & Precautions
Medpurine Product Label
The following document was submitted to the FDA by the labeler of this product Purinepharma Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient (in each tablet): Aspirin 81 mg (NSAID)
nonsteroidal anti-inflammatory drug
Otc - Purpose
Purpose: Pain reliever
Indications & Usage
Uses 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 of aspirin.
Warnings
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
Otc - Do Not Use
Do not use if you are allergic to aspirin or any other pain reliever / fever reducer.
Otc - Ask Doctor
you are taking a diuretic
you have a history of stomach problems, such as heartburn
You have high blood pressure, heart disease, liver cirrhosis, kidney disease
You have asthma
Ask a doctor or pharmacist before use if you are taking any other drugs containing an NSAID (prescription or nonprescription)
taking a blood thinning (anticoagulant) or steroid drug
taking a prescription drug for diabetes, gout or arthritis
Otc - When Using
Stop use and ask a doctor if an allergic reaction occurs. Seek medical right away. 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, fever gets worse or lasts more than 3 days, any new symptoms occur, ringing in the ears or a loss of hearing occurs
Otc - Pregnancy Or Breast Feeding
Otc - Keep Out Of Reach Of Children
Dosage & Administration
Adults and children 12 years and older: Take 4-8 tablets every 4 hours while symptoms last, but not more than 48 tablets in 24 hours unless directed by a doctor.
Children under 12: Ask a doctor.
Storage And Handling
Other information save carton for full directions and warnings. Store at room temperature
Inactive Ingredient
Inactive ingredients: Microcrystalline Cellulose, Modified Starch, Pregelatinized Starch, Colloidal Silicon Dioxide, Stearic Acid, Hypromellose, Methacrylic Acid Copolymer Dispersion, Triethyl Citrate, Polysorbate 80, Talc, FD&C Yellow #10, FD&C Yellow #6, Titanium Dioxide.
How Supplied
NDC 58599-016-30: 120 Count in a Bottle
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