Label: ANTIEMETIC GASTROKINETIC PILERAN- metoclopramide 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 18, 2013

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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.

  • Formula:

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

  • Indications:

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

  • 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.

  • 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)

  • Contraindications:

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

  • Dose:

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

  • Presentation:

    20 ml dropper

    Keep between 41 degree and 86 degree F

  • 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

  • Product Label

    Pileran BottlePileran InsertPileran Outer

  • INGREDIENTS AND APPEARANCE
    ANTIEMETIC GASTROKINETIC PILERAN  
    metoclopramide hydrochloride solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58670-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METOCLOPRAMIDE HYDROCHLORIDE (UNII: W1792A2RVD) (METOCLOPRAMIDE - UNII:L4YEB44I46) METOCLOPRAMIDE5 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58670-001-201 in 1 CARTON
    120 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/17/2013
    Labeler - Holliday-Scott S.A. (970253217)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holliday-Scott S.A.970253217manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Ipca Laboratories Limited862179827api manufacture