Label: ANTIDIARRHEAL LOPERAMIDE- loperamide hydrochloride solution

  • 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 31, 2013

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  • Antidiarrheal LOPERAMIDE Solution

    Oral Way For dogs and cats  Loperamide is meperidine derivative.  The antidiarrheic action is achieved by its modulating effect on intestinal motility, which, in turn is achieved through the stimulation of the rhythmic segmentation (acting on circular smooth muscle) and by decreasing the peristalsis (with either no effect on the longitudinal smooth muscle, or relaxing it), as well as due to the antisecretory effect, increasing the absorption of nutrients, water and electrolytes, achieved by blocking the channel of calcium or by inhibiting the calcium binding protein, calmodulin

  • Formula:

    Each ml of oral solution contains:
    Loperamide hydrochloride...........2 mg Vehicle q.s.

  • Indications:

    Symptomatic treatment of acute and chronic diarrhea.

  • KEEP OUT OF REACH OF CHILDREN.

    National poison centre: 1-800-222-1222 (Puerto Rico and USA)
    National poison centre: 0-800-333-0160 / (54 11) 4654-6648 (Argentina)

  • Side effects:

    Constipation, after prolonged treatment.

  • Contraindications:

    Toxigenic Infections with e. Coli, Salmonella, Shigella and Pseudomembranous Colitis caused by antibiotics. In these cases, diarrhea plays a protective role, since it accelerates the elimination of micro-organisms, thus avoiding the proliferation of the same, the invasion of mucosa and the absorption of toxic products (enterotoxemia).

  • Dose:

    Dogs and cats: 0.1 mg/2.204 Lb. equivalent to 1 drop per 2.204 Lb. every 8 hours.

    During the administration of the product, you will observe:
    (1) Lower frequency in bowel movements.
    (2) Lower volume of stool.
    (3) Changes in consistency: from fluid to solid.
    (4) Control of diarrhea.

  • Presentation:

    10 ml dropper

    Keep between 40 degree and 95 degree F

  • Elaborado por: / Elaborated by:

    HOLLIDAY-SCOTT S.A.
    Int. Neyer 924 - (B1643GAT) Beccar
    Buenos Aires - Argentina

    Tel./Fax: (54-11) 4732-0222
    E-mail: info@holliday.com.ar
    Distributed in Puerto Rico by
    International Med Distributors
    PO BOX 627 Dorado PR 00646 - E-mail:
    info@internationalmeddistributors.com

    7 798042 365296

  • Antidiarrheal LOPERAMIDE Solution 10ml (58670-000-10)

    Loperamide BottleLoperamide InsertLoperamide Outer

  • INGREDIENTS AND APPEARANCE
    ANTIDIARRHEAL LOPERAMIDE 
    loperamide hydrochloride solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58670-000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58670-000-101 in 1 CARTON
    110 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/31/2013
    Labeler - Holliday-Scott S.A. (970253217)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holliday-Scott S.A.970253217manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Vasudha Pharma Chem Limited725431626api manufacture