Label: ATROPINE SULFATE injection, solution

  • NDC Code(s): 58005-354-04
  • Packager: Sparhawk Laboratories, Inc
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 20, 2015

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  • INDICATIONS & USAGE

    (0.54 mg/mL)

    FOR ANIMAL USE ONLY

    KEEP OUT OF REACH OF CHILDREN

    CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.


    INDICATIONS

    For use in Dogs and Cats as an antidote in the treatment of organophosphate insecticide poisoning; to reduce salivation, bronchial secretions or intestinal peristalsis associated with colic or diarrhea, and as a preanesthetic adjuvant.

  • DOSAGE AND ADMINISTRATION:

    Dogs and Cats:  Inject intravenously, intramuscularly, or subcutaneously, 1 mL for each 20 lbs of body weight as a preanesthetic adjuvant, or to reudce salivation, bronchial secretions, or intestinal peristalsis associated with colic or diarrhea. 

    As an antidote for parasympathomimetic drugs, inject 1 mL for each 5 lbs of body weight administered to effect and repeat as necessary.  It is suggested that 1/4 of the dosage be injected intravenously and the remainder intramuscularly or subcutaneously.

  • WARNING

    Poisonous alkaloid.

    Antidotes:  Warmth, Emetics, Cholinergics

  • COMPOSITION

    Each mL of sterile solution contains:


    Atropine Sulfate  ............................  0.54 mg
    Sodium Chloride .................................  9 mg
    Benzyl Alcohol  ..................................  1.5%
    Water for Injection  ................................  QS

  • STORAGE AND HANDLING

    Store at controlled room temperature between 15o and 30oC (59o-86oF)

    PROTECT FROM LIGHT

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • PRINCIPAL DISPLAY PANEL

    SLI Atropine Sulfate SA label

  • INGREDIENTS AND APPEARANCE
    ATROPINE SULFATE  
    atropine sulfate injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:58005-354
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE0.54 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58005-354-04100 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/1997
    Labeler - Sparhawk Laboratories, Inc (147979082)