Label: ANTIEMETIC GASTROKINETIC PILERAN  - metoclopramide hydrochloride solution 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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 LABEL Item Code (Source) NDC:58670-001
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METOCLOPRAMIDE HYDROCHLORIDE (METOCLOPRAMIDE) 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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