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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Doans (NDC 55741-224). 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 other, active ingredient (in each caplet), purpose, use, reye's syndrome, allergy alert, stomach bleeding warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Magnesium salicylate tetrahydrate 580 mg (NSAID)
nonsteroidal anti-inflammatory drug
(equivalent to 467.2 mg of anhydrous magnesium salicylate)Pain reliever
for the temporary relief of minor backache pain
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.
Magnesium salicylate may cause a severe allergic reaction, which may include:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
Ask a doctor or pharmacist before use if you are taking a prescription drug for
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use magnesium salicylate 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.
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.
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin
1-800-790-6417
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