DOCUSATE SODIUM capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stool Softener

Authorization status:

unapproved drug other

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM CAPSULE, LIQUID FILLED
CARDINAL HEALTH
_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._
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DRUG FACTS
ACTIVE INGREDIENT _(IN EACH SOFTGEL)_
Docusate Sodium 100mg
PURPOS E
Stool Softener
US ES
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WARNINGS
DO NOT USE
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ASK A DOCTOR BEFORE USE IF you have noticed a sudden change in bowel
habits that persists over a
period of 2 weeks.
STOP USE AND ASK A DOCTOR IF
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IF YOU ARE PREGNANT OR BREAST-FEEDING, ask a health professional
before use.
This unit dose package is not child resistant and is Intended for
Institutional Use Only.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of
overdose, get medical help or contact
a Poison Control Center right away.
This package is intended for institutional use only.
Consult a physician before the use of this product.
DIRECTIONS
•
for the prevention of dry, hard stools
for relief of occasional constipation.
This product generally produces a bowel movement within 12 to 72
hours.
if you are currently taking mineral oil, unless directed by a doctor
when abdominal pain, nausea, or vomiting are present
for longer than 1 week unless directed by a doctor
you have rectal bleeding
you fail to have a bowel movement after use
Adults and children over 12 years of age and over: take 1-3 softgels
daily. This dose may be taken
as a single daily dose or in divided doses
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OTHER INFORMATION
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INACTIVE INGREDIENTS
FD&C Red No. 40, FD&C Yellow No.6, Gelatin, Bovine Bone, Glycerol Palm
Free, Polyethylene
Glycol 400 NF, Purified Water, Sorbitol Special 76%.
SKY
Mfg. By:
Aenova Holding GmbH
14193 SW 119
Ave.,
Miami, FL 33186-6013
Distributed by
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddington Road
Concord, NC 28027
Validated with McKesson's PROmanager-Rx Automated storage & dispensing
system for Package-
Ready Oral solids
www.PROmanager-Rx.c