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NDC 49314-0748-00 Unishield Back Pain Relief 580 mg/1 Details
Unishield Back Pain Relief 580 mg/1
Unishield Back Pain Relief is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Unishield. The primary component is MAGNESIUM SALICYLATE.
Product Information
NDC | 49314-0748 |
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Product ID | 49314-0748_e82afa5e-41be-2959-e053-2a95a90a07de |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Unishield Back Pain Relief |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Magnesium salicylate |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 580 |
Active Ingredient Units | mg/1 |
Substance Name | MAGNESIUM SALICYLATE |
Labeler Name | Unishield |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part343 |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 49314-0748-00 (49314074800)
NDC Package Code | 49314-0748-0 |
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Billing NDC | 49314074800 |
Package | 40 PACKET in 1 BOX (49314-0748-0) / 2 TABLET, FILM COATED in 1 PACKET |
Marketing Start Date | 2022-09-26 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e56e6162-4c3f-5e68-e053-2a95a90a9c74 Details
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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
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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.
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PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
UNISHIELD BACK PAIN RELIEF
magnesium salicylate tablet, film coated |
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Labeler - Unishield (790677053) |
Registrant - Unifirst First Aid Corporation (832947092) |