Magnesium salicylate

FDA Drug Profile — Doans Extra Strength, Doans Maximum Strength

Drug Details

Generic Name
Magnesium salicylate
Brand Names
Doans Extra Strength, Doans Maximum Strength
Application Number
part343
Sponsor
Dr. Reddy's Laboratories Inc.
NDC Codes
2
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
MAGNESIUM SALICYLATE

Indications and Usage

INDICATIONS & USAGE Uses For the temporary relief of minor backache pain

Warnings

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 DO NOT USE Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer. ASK DOCTOR Ask a doctor before use if 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 have asthma you are taking a diuretic ASK DOCTOR/PHARMACIST Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis STOP USE Stop use and ask a doctor if an allergic reaction occurs. Seek medical help 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 ringing in the ears or loss of hearing occurs new symptoms occur pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present These could be signs of a serious condition. PREGNANCY OR BREAST FEEDING If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 (1-800-222-1222) right away.