Active Ingredient
Active ingredient (in each caplet)
Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg
(equivalent to 467.2 mg of anhydrous magnesium salicylate)
*nonsteroidal anti-inflammatory drug
The following Structured Product Label (SPL) was submitted to the FDA by Wildman Business Group for the product Back Pain Relief (NDC 84269-2550). 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 active ingredient, purpose, indications & usage, warnings, reye's syndrome:, allergy alert:, stomach bleeding warning:, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each caplet)
Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg
(equivalent to 467.2 mg of anhydrous magnesium salicylate)
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Uses
For the temporary relief of minor backache pain
Warnings
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 before use if
Ask a doctor or pharmacist before use if you are taking a prescription drug for
Stop use and ask a doctor if
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 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. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours.
Do not use unless directed by a doctor
Other information
Inactive ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin
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