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Name:Backache Relief
Manufacturer:Woonsocket Prescription Center, Incorporated
Category:Over-the-counter (OTC) Marketed Drugs


BACKACHE RELIEF - magnesium salicylate tablet, film coated 
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each caplet)

Magnesium salicylate tetrahydrate 580 mg (NSAID)*

(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

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 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 asthma
  • you are taking a diuretic
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease

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
  • have stomach pain that does not get better
  • feel faint
  • have bloody or black stools
  • vomit blood
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • redness or swelling is present
  • 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

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.

Directions

  • 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 unless directed by a doctor

Inactive ingredients

cellulose, hypromellose, macrogol, magnesium stearate, polydextrose, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

PRODUCT PACKAGE

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

CVS®

pharmacy

Compare to the active ingredient

in Extra Strength Doan's®†

See New Warnings

Information

Extra Strength

BACKACHE

RELIEF

PAIN RELIEVER

MAGNESIUM SALICYLATE, (NSAID)

RELIEVES

BACKACHE PAIN

24 ANALGESIC CAPLETS

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

50844          REV0110B33808

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2010 CVS/pharmacy

www.cvs.com                     1800-shop-CVS

Product Label

BACKACHE RELIEF  
magnesium salicylate tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-338
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Magnesium Salicylate (Salicylic Acid) Magnesium Salicylate 580 mg
Inactive Ingredients
Ingredient Name Strength
Powdered Cellulose  
Hypromellose  
Magnesium Stearate  
Polydextrose  
Stearic Acid  
Titanium Dioxide  
Triacetin  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17mm
Flavor Imprint Code 44;338
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-338-08 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 24 TABLET, FILM COATED ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (59779-338-08)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/07/1998

Labeler - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
Name Address ID/FEI Operations
L.N.K. International, Inc 832867894 MANUFACTURE

Revised: 08/2010 WOONSOCKET PRESCRIPTION CENTER, INCORPORATED



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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