Label: ANTIEMETIC GASTROKINETIC PILERAN - metoclopramide hydrochloride solution
- NDC Code(s): 58670-001-20
- Packager: Holliday-Scott S.A.
- 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.
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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.Close
Each ml of oral solution contains:Close
Metoclopramide hydrochloride...........5 mg Vehicle q.s.
Vomiting of different etiology. Nausea. Gastric emptiness. Reflux espphagitis Preparation for x-ray exams of the gastrointestinal tract.Close
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.Close
- KEEP OUT OF REACH OF CHILDREN.
National poison centre: 1-800-222-1222 (Puerto Rico and USA)Close
National poison centre: 0-800-333-0160 / (54 11) 4654-6648 (Argentina)
Presence of gastrointestinal sharp foreign bodies. Mechanical obstruction. Digestive perforation. It should not be used in combination with anticholinergics or opiates.Close
Dogs and cats: 1 ml (20 drops) per 22 Lb of body weight every 6 - 8 hs.Close
20 ml dropper
Keep between 41 degree and 86 degree FClose
- Elaborated by:
Int. Neyer 924 - (B1643GAT) Beccar
Buenos Aires - Argentina
Tel./Fax: (54-11) 4732-0222
Distributed in Puerto Rico by
International Med Distributors
PO BOX 627 Dorado PR 00646 - E-mail:
7 798042 365395Close
- 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