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Backache Relief

Rite Aid

Rite Aid 44-338


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Magnesium salicylate tetrahydrate 580 mg (NSAID)*
(equivalent to 467.2 mg of anhydrous magnesium salicylate)

*nonsteroidal anti-inflammatory drug 

Pain Reliever 

for the temporarily relief of minor backache pain 

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 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 alcoholic 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

  • 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 you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis 

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have stomach pain that does not get better
  • an allergic reaction occurs.  Seek medical help right away.
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs
  • 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. 

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 right away. 

  • drink a full glass of water with each dose
  • adults: 2 caplets every 6 hours, not to exceed 8 caplets in 24 hours
  • children under 12 years: do not use u nless directed by a doctor 

Backache Relief Other information

  • each caplet contains: magnesium 50 mg
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

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

Principal Display Panel

RITE AID
PHARMACY®

**Compare to the active ingredient in Extra Strength Doans® Caplets

EXTRA STRENGTH

pain relief
backache relief
magnesium salicylate  tetrahydrate (NSAID) 
pain reliever

relieves
backache
pain

48 CAPLETS

**This product is not manufactured or distributed by Novartis Consumer Health, owner of the registered trademark Extra Strength Doan's®.
50844    REV0512A33822

DISTRIBUTED BY:
Rite Aid
30 Hunter Lane, Camp Hill, PA 17011

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BORKEN OR SHOWS ANY SIGNS OF TAMPERING

Backache Relief
Rite Aid 44-338

Backache Relief

Magnesium Salicylate Tetrahydrate CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11822-0338
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Magnesium Salicylate SALICYLIC ACID 580 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
POLYETHYLENE GLYCOLS
STEARIC ACID
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
WHITE 17 mm 44;338 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 48 in 1 BLISTER PACK
2 NDC:11822-0338-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 1998-11-07


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Be sure to consult your doctor before taking any medication!
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