Label: UNISHIELD BACK PAIN RELIEF- magnesium salicylate tablet, film coated
- NDC Code(s): 49314-0748-0
- Packager: Unishield
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
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
■ 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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
UNISHIELD BACK PAIN RELIEF
magnesium salicylate tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-0748 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) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) TRIACETIN (UNII: XHX3C3X673) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYDEXTROSE (UNII: VH2XOU12IE) Product Characteristics Color 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:49314-0748-0 40 in 1 BOX 09/26/2022 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 09/26/2022 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092)