Magnesium Salicylate Tetrahydrate

FDA Drug Profile — Medique Back Pain Relief

Drug Details

Generic Name
Magnesium Salicylate Tetrahydrate
Brand Names
Medique Back Pain Relief
Application Number
M013
Sponsor
Unifirst First Aid Corporation
NDC Codes
1
Dosage Forms
TABLET, FILM COATED
Routes
ORAL
Active Ingredients
MAGNESIUM SALICYLATE

Indications and Usage

Uses For the temporary releif of minor backache pain

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: Magnesium salicylate 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 alcohol drinks every day while using this product ■ take more or for a longer time than directed