SINGLE-USE- docusate sodium enema

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

Compra'l ara

Descargar Fitxa tècnica (SPC)
04-02-2022

ingredients actius:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)

Disponible des:

Covetrus

Vía de administración:

RECTAL

tipo de receta:

OTC

indicaciones terapéuticas:

Single-Use Enema For Use in dogs and cats

Estat d'Autorització:

unapproved drug other

Fitxa tècnica

                                SINGLE-USE- DOCUSATE SODIUM ENEMA
COVETRUS
_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._
----------
Single-Use Enema
For Use in dogs and cats
Each syringe contains a solution of dioctyl sodium sulfosuccinate (250
mg) in glycerine
with sorbic acid as a preservative.
covetrus
NDC: 11695-3202-1
Single-use enema
For use in dogs and cats
Each syringe contains a solution of dioctyl sodium sulfosuccinate (250
mg) in glycerine
with sorbic acid as a preservative.
Reorder #002515
12 mL (0.41 fl oz)
Questions? (855) 724-3461
Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com
AH-002515-L-02
Rev. 0619
SINGLE-USE
docusate sodium enema
PRODUCT INFORMATION
PRODUCT TYPE
OTC ANIMAL DRUG
ITEM CODE (SOURCE)
NDC:11695-3202
ROUTE OF ADMINISTRATION
RECTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
DOCUSATE SODIUM
250 mg in 12 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SORBIC ACID (UNII: X045WJ989B)
GLYCERIN (UNII: PDC6A3C0OX)
PRODUCT CHARACTERISTICS
COLOR
blue
SCORE
SHAPE
SIZE
FLAVOR
IMPRINT CODE
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1 NDC:11695-3202-1
12 in 1 CARTON
1
12 mL in 1 SYRINGE
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
unapproved drug
other
05/01/2020
LABELER -
Covetrus (603750329)
REGISTRANT -
Pegasus Laboratories, Inc (108454760)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Covetrus
Pegasus Laboratories, Inc
108454760
manufacture, analysis
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Cytec Industries Inc.
013118166
api manufacture
Revised: 2/2022
                                
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