ORAL-PRO SODIUM SALICYLATE WITH CAFFEINE- sodium salicylate solution 
Aurora Pharmaceutical, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ORAL-PRO™
Sodium Salicylate
Concentrate 60% w/v
with Caffeine 5.7% w/v

ACTIVE INGREDIENTS
Sodium Salicylate60% w/v
Caffeine5.7% w/v

INDICATIONS

For use in the drinking water of poultry and swine as an aid in reducing pain, fever and inflammation.

DIRECTIONS FOR USE

For Analgesic and Antipyretic Use

Water Proportioner Use:

Add 6.5 ounces (192 mL) of Sodium Salicylate 60% Concentrate with Caffeine 5.7% to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 11.3 mg/lb (25 mg/kg) body weight daily.

Livestock Tank Use:

Add 6.5 ounces (192 mL) of Sodium Salicylate 60% Concentrate with Caffeine 5.7% to 128 gallons of drinking water. This will achieve a target dose of 11.3 mg/lb (25 mg/kg) body weight daily.

For Anti-Inflammatory/Anti-Prostaglandin Use — Day 1

Water Proportioner Use:

Add 14 ounces (414 mL) of Sodium Salicylate 60% Concentrate with Caffeine 5.7% to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.

Livestock Tank Use:

Add 14 ounces (414 mL) of Sodium Salicylate 60% Concentrate with Caffeine 5.7% to 128 gallons of drinking water. This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.

Day 2 through 7

Water Proportioner Use:

Add 8 ounces (236 mL) of Sodium Salicylate 60% Concentrate with Caffeine 5.7% to make 1 gallon of stock solution and administer through a medicator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 13.6 mg/lb (30 mg/kg) body weight daily.

Livestock Tank Use:

Add 8 ounces (236 mL) of Sodium Salicylate 60% Concentrate with Caffeine 5.7% to 128 gallons of drinking water. This will achieve a target dose of 13.6 mg/lb (30 mg/kg) body weight daily.

Prepare fresh solutions daily. Repeat as necessary.

Warning

Do not administer concentrated solution by direct oral administration — gastro-intestinal irritation or overdose may occur. Do not use in piglets less than 3 weeks of age.

Store upright at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F).

Do not use if allergic or sensitive to the active ingredients.

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.

Take time image

MANUFACTURED IN THE USA

REORDER NO: 21003

MANUFACTURED BY:
Aurora Pharmaceutical, Inc.
NORTHFIELD, MINNESOTA 55057
1-888-215-1256
www.aurorapharmaceutical.com

IN 50-1110 02-2021

PRINCIPAL DISPLAY PANEL - 3.79 Liter Bottle Label

NDC 51072-039-01

ORAL-PRO®

Sodium Salicylate
Concentrate 60% w/v
with Caffeine 5.7% w/v

For Use in Livestock Only

Keep Out of Reach of Children

Net Contents:
1 Gallon (3.79 Liters)

AURORA PHARMACEUTICAL®

PRINCIPAL DISPLAY PANEL - 3.79 Liter Bottle Label

ORAL-PRO SODIUM SALICYLATE  WITH CAFFEINE
sodium salicylate solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-039
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE60 g  in 100 mL
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE5.7 g  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51072-039-013790 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/16/2011
Labeler - Aurora Pharmaceutical, Inc. (832848639)
Establishment
NameAddressID/FEIBusiness Operations
Aurora Pharmaceutical, Inc.832848639manufacture

Revised: 2/2023
Document Id: c02605f5-cce4-454a-8967-028790fedfb8
Set id: d11b86c2-3f94-46cd-8b4d-9a6405d50b76
Version: 14
Effective Time: 20230228
 
Aurora Pharmaceutical, Inc.