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Magnesium Salicylate Tetrahydrate

OTC Oral RxCUI 198742
Contents

Overview

Active ingredient
Magnesium Salicylate
Route
Oral
Label date
2025-09-08

Indications and usage

Uses For the temporary releif of minor backache pain

Purpose

Pain reliever

Dosage and administration

Directions

  • drink a full glass of water with each dose Adults and children: (12 years and over) Take 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours. Children under 12 years: Do not use unless directed by a doctor

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

if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.

Ask a doctor before use if

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 a doctor or pharmacist before use if

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

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
  • if 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. I t is especially important not to use magnesium salicylate at 20 weeks or later in pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active ingredient (label)

(in each caplet) Magnesium Salicylate Tetrahydrate (NSAID*) 580 mg (equivalent to 467.2 mg of anhydrous magnesium salicylate) *nonsteroidal anti-inflammatory drug

Inactive ingredients

s hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin

Keep out of reach of children

of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.