Label: ATROPINE SULFATE injection, solution

  • Category: PRESCRIPTION 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 April 27, 2018

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    INJECTABLE SOLUTION

    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.

    Each mL contains:

    Atropine Sulfate .....................  15 mg
    Sodium Chloride  .....................  9 mg
    Benzyl Alcohol  ..........................  1%
    Water for Injection  ....................  q.s.

  • INDICATIONS

    For use as an antidote in the treatment of organophosphate insecticide poisoning of cattle, horses and sheep.

  • WARNING

    Poisonous alkaloid.  Keep out of reach of children.  Antidotes: warmth, emetics, cholinergics

  • STORAGE AND HANDLING

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

    TAKE TIME OBSERVE LABEL DIRECTIONS

  • DOSAGE AND ADMINISTRATION

    INITIAL DOSE:

    Cattle:  20 mg per 100 lbs. of body weight
    Horses:  6.5 mg per 100 lbs. of body weight
    Sheep:  20 mg per 100 lbs. of body weight

    The recommended average initial dose should be split, injecting one quarter (1/4) to one-third (1/3) slowly I.V. and the remainder I.M. or S.C.  After symptoms appear to be under control, repeated maintenance doses should be administered at 3 to 6 hour intervals based on the individual response of the animal.

  • PRINCIPAL DISPLAY PANEL

    PAT Atropine

  • INGREDIENTS AND APPEARANCE
    ATROPINE SULFATE 
    atropine sulfate injection, solution
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:14043-232
    Route of AdministrationINTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE 15 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14043-232-05100 mL in 1 VIAL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/29/2017
    Labeler - Patterson Veterinary (006962500)