Label: BACKACHE RELIEF- magnesium salicylate tablet, film coated
- NDC Code(s): 59779-338-08
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated October 26, 2018
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- Active ingredient (in each caplet)
tetrahydrate 580 mg (NSAID)*
(equivalent to 467.2 mg of anhydrous magnesium salicylate)
*nonsteroidal anti-inflammatory drug
for the temporary relief of minor backache painClose
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:
- facial swelling
- asthma (wheezing)
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 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
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
- 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 (1-800-222-1222) 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 unless directed by a doctor
- 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
- Inactive ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetinClose
- Questions or comments?
- Principal Display Panel
Compare to the active
ingredient in Extra Strength Doan's®†
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
†This product is not manufactured or distributed by Novartis
Consumer Health, Inc., owner of the registered trademark Extra
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2015 CVS/pharmacy CVS.com®
1-800-SHOP CVS V-11112
- INGREDIENTS AND APPEARANCE
magnesium salicylate tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-338 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SALICYLATE (UNII: 41728CY7UX) (SALICYLIC ACID - UNII:O414PZ4LPZ) MAGNESIUM SALICYLATE 580 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIACETIN (UNII: XHX3C3X673) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color WHITE Score no score Shape OVAL Size 17mm Flavor Imprint Code 44;338 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-338-08 3 in 1 CARTON 11/07/1998 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 11/07/1998 Labeler - CVS Pharmacy (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(59779-338) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(59779-338) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(59779-338) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(59779-338)