Label: BACK PAIN RELIEF EXTRA STRENGTH DOANS- magnesium salicylate tablet, film coated
- NDC Code(s): 84269-2550-2
- Packager: Wildman Business Group
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 1, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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
Do not use if you are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
ASK DOCTOR
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 DOCTOR/PHARMACIST
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- gout
- diabetes
- arthritis
STOP USE
Stop use 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
- 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. 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.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- Principal Display Panel – 50 Caplet Box Label
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INGREDIENTS AND APPEARANCE
BACK PAIN RELIEF EXTRA STRENGTH DOANS
magnesium salicylate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84269-2550 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 POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYDEXTROSE (UNII: VH2XOU12IE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) TRIACETIN (UNII: XHX3C3X673) Product Characteristics Color white (white) Score no score Shape CAPSULE (Caplet) Size 17mm Flavor Imprint Code 44;338 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:84269-2550-2 50 in 1 BOX 07/01/2024 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 07/01/2024 Labeler - Wildman Business Group (016677338) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 MANUFACTURE(84269-2550) Establishment Name Address ID/FEI Business Operations Medique Products 086911794 PACK(84269-2550) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 PACK(84269-2550)