SODIUM SALICYLATE

Aurora Pharmaceutical LLC

ORAL-PRO™ Sodium Salicylate Concentrate 48.6% w/v

FULL PRESCRIBING INFORMATION: CONTENTS*

• CALF LABEL CLAIM
  • Indications For Use, Calves
  • Contraindications, Calves
  • Dosage, Calves
• SWINE AND POULTRY LABEL CLAIM
  • Indications
• DIRECTIONS FOR USE
  • For Analgesic and Antipyretic Use
  • For Anti-Inflammatory/Anti-Prostaglandin Use
  • Following Days
• Warning
• Caution
• PRINCIPAL DISPLAY PANEL - 3.79 Liters Bottle Label

FULL PRESCRIBING INFORMATION

CALF LABEL CLAIM

Indications For Use, Calves

Supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g., anti-infective) therapy if necessary.

Contraindications, Calves

Do not use Sodium Salicylate in neonates or calves less than 2 weeks of age.

Dosage, Calves

40 mg Sodium Salicylate per kg body weight (4 mL per 100 lbs.) once daily, for 1–3 days. Administer orally in drinking water or milk (replacer).

Recommended withdrawal period for all food animals following use at "usual dosages": meat 24 hours.

SWINE AND POULTRY LABEL CLAIM

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 8 ounces (236 mL) of Sodium Salicylate 48.6% Concentrate 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 8 ounces (236 mL) of Sodium Salicylate 48.6% Concentrate 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

Water Proportioner Use:

Add 16 ounces (473 mL) of Sodium Salicylate 48.6% Concentrate 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 16 ounces (473 mL) of Sodium Salicylate 48.6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 22.7 mg/lb (50 mg/kg) body weight daily.

Following Days

Water Proportioner Use:

Add 10 ounces (296 mL) of Sodium Salicylate 48.6% Concentrate 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 10 ounces (296 mL) of Sodium Salicylate 48.6% Concentrate 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 4 weeks of age.

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

Do not use in food-producing animals less than 1 day prior to slaughter.

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.

MANUFACTURED IN THE USA

REORDER NO: 21004

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1108 REV 03

PRINCIPAL DISPLAY PANEL - 3.79 Liters Bottle Label

NDC 51072-038-01

ORAL-PRO™

Sodium Salicylate
Concentrate 48.6% w/v

For Use in Livestock Only

Keep Out of Reach of Children

Net Contents:
1 Gallon (3.79 Liters)

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