Medpurine
FDA Label NDC 58599-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purinepharma Llc for the product Medpurine (NDC 58599-016). 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 - when using, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

Ask a doctor before use if the stomach bleeding warning
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

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.

Otc - 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.

Dosage & Administration

Directions drink a full glass of water with each dose. Swallow whole. Do not chew or crush. Do not exceed recommended dose.
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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