Label: ORAL-PRO SODIUM SALICYLATE WITH CAFFEINE- sodium salicylate solution
- NDC Code(s): 51072-039-01
- Packager: Aurora Pharmaceutical, Inc.
- Category: OTC ANIMAL DRUG LABEL
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Drug Label Information
Updated February 28, 2023
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- Official Label (Printer Friendly)
- DESCRIPTION
- INDICATIONS
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DIRECTIONS FOR USE
For Analgesic and Antipyretic Use
For Anti-Inflammatory/Anti-Prostaglandin Use — Day 1
Day 2 through 7
- Warning
- STORAGE AND HANDLING
- FOOD SAFETY WARNING
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Caution
Keep container closed when not in use. Product may solidify at cold storage temperatures. Place container in room temperature storage, which will thaw the solution, or place in warm water. Gently invert container to ensure uniformity of product.
Gradual darkening will not affect product stability.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.79 Liter Bottle Label
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INGREDIENTS AND APPEARANCE
ORAL-PRO SODIUM SALICYLATE WITH CAFFEINE
sodium salicylate solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51072-039 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE 60 g in 100 mL CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 5.7 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51072-039-01 3790 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/16/2011 Labeler - Aurora Pharmaceutical, Inc. (832848639) Establishment Name Address ID/FEI Business Operations Aurora Pharmaceutical, Inc. 832848639 manufacture