ORAL-PRO SODIUM SALICYLATE

Manufacturer
Aurora Pharmaceutical, Inc.
Effective date
2025-05-29
Label type
OTC ANIMAL DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 02:44:42

Label at a glance#

ProductORAL-PRO SODIUM SALICYLATE with Caffeine
Active ingredientSODIUM SALICYLATE, CAFFEINE
Label structure9 sections

Dosage and administration

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 w...

Storage and handling

Store upright up to 25° C (77° F) with brief excursions to 40° C (104° F).

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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

INDICATIONS

VETERINARY INDICATIONS SECTION

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

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

For Analgesic and Antipyretic Use

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

WARNINGS SECTION

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.

STORAGE AND HANDLING SECTION

Store upright up to 25° C (77° F) with brief excursions to 40° C (104° F).

FOOD SAFETY WARNING SECTION

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

Caution

WARNINGS AND PRECAUTIONS SECTION

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

Take time imageTake 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 12/2024

PRINCIPAL DISPLAY PANEL - 3.79 Liter Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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®

IN50-1110 12-2024 Principal DisplayIN50-1110 12-2024 Principal Display

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51072-039-01ORAL-PRO SODIUM SALICYLATEwith Caffeine3790 mL in 1 BOTTLESOLUTION379015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338E6
SODIUM SALICYLATEACTIVE INGREDIENTWIQ1H85SYP6
CAFFEINEACTIVE MOIETY3G6A5W338E6
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ6

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51072-03951072-039-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM SALICYLATEWIQ1H85SYPACTIB
CAFFEINE3G6A5W338EACTIB

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.