Label: AQUAPRIME LIQUID SODIUM SALICYLATE- sodium salicylate liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated July 28, 2023

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  • Indications

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

    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 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.

  • Warnings

    Not for use in lactating dairy cattle.

    A withdrawal period of 24 hours is recommended in meat.

    Not for human use.

    Keep container tightly closed.

    Keep out of reach of children.

    Store at room temperature.

    Warning: Do not administer concentrated solution by direct oral administration — gastrointestinal irritation or overdose may occur. Do not use in piglets less than 4 weeks of age. Store at controlled room temperature between 15°-30° C (59°-86° F).

  • 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/b (25 mg/kg) body weight daily. 

    Livestock Tank Use: 8 ounces (473 ml) of Sodium Salicylate 48 6% Concentrate to 128 gallons of drinking water. This will achieve a target dose of 11.3 mg/b (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% Concontrate 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 mediator metered at 1:128 (1 ounce per gallon). This will achieve a target dose of 13.6 mg/b (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.

  • PRINCIPAL DISPLAY PANEL

    BRE_AquaPrime_Sodium_Salicylate_48_1_Gal

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  • INGREDIENTS AND APPEARANCE
    AQUAPRIME LIQUID SODIUM SALICYLATE 
    sodium salicylate liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86050-2486
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM SALICYLATE (UNII: WIQ1H85SYP) (SALICYLIC ACID - UNII:O414PZ4LPZ) SODIUM SALICYLATE486 g  in 1 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86050-2486-13.79 L in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/27/2023
    Labeler - Blendpack, Inc. (043362034)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blendpack, Inc.043362034manufacture