Label: ANTIEMETIC GASTROKINETIC PILERAN - metoclopramide hydrochloride solution

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

Drug Label Information

Updated 07/13

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  • Antiemetic Gastrokinetic PILERAN

    Metoclopramide Oral way Drops for dogs and Cats. PILERAN is a potent antiemetic drug which acts at central and peripheral levels and exerts a gastrokinetic effect at gastric, pyloric, duodenal and jejunal level.

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  • Formula:

    Each ml of oral solution contains:
    Metoclopramide hydrochloride...........5 mg Vehicle q.s.

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  • Indications:

    Vomiting of different etiology. Nausea. Gastric emptiness. Reflux espphagitis Preparation for x-ray exams of the gastrointestinal tract.

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  • Precautions:

    It is not recommended during the early stages of pregnancy. Side effects are dose-dependent and include nervousness, hyperexcitability, restlessness, depression and constipation in case of long-term therapy.

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  • 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)

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  • Contraindications:

    Presence of gastrointestinal sharp foreign bodies. Mechanical obstruction. Digestive perforation. It should not be used in combination with anticholinergics or opiates.

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  • Dose:

    Dogs and cats: 1 ml (20 drops) per 22 Lb of body weight every 6 - 8 hs.

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  • Presentation:

    20 ml dropper

    Keep between 41 degree and 86 degree F

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  • 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 365395

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  • Product Label
  • INGREDIENTS AND APPEARANCE
    ANTIEMETIC GASTROKINETIC PILERAN  
    metoclopramide hydrochloride solution
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58670-001
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46) METOCLOPRAMIDE 5 mg  in 1 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58670-001-20 1 in 1 CARTON
    1 20 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/17/2013
    Labeler - Holliday-Scott S.A. (970253217)
    Establishment
    Name Address ID/FEI Business Operations
    Holliday-Scott S.A. 970253217 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Ipca Laboratories Limited 862179827 api manufacture
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