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:

Contract Pharmacy Services-PA

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 100 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stool softener - relieves occasional constipation (irregularity) generally produces a bowel movement in 12 to 72 hours generally produces a bowel movement in 12 to 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM CAPSULE, LIQUID FILLED
CONTRACT PHARMACY SERVICES-PA
_Disclaimer: Most OTC drugs are not reviewed and approved by 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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DOCUSATE SODIUM 100 MG
DRUG FACTS
ACTIVE INGREDIENT (IN EACH CAPSULE)
Docusate sodium 100 mg
PURPOSE
Stool softener
USES
relieves occasional constipation (irregularity)
generally produces a bowel movement in 12 to 72 hours
WARNINGS
DO NOT USE
if you are presently taking mineral oil, unless told to do so by a
doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
stomach pain
nausea
vomiting
noticed a sudden change in bowel movements that continues over a
period of 2 weeks
STOP USE AND ASK A DOCTOR IF
you have rectal bleeding or fail to have a bowel movement after use of
a laxative.
These could be signs of a serious condition.
you need to use a stool softener laxative for more than 1 week
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
Center right away.
DIRECTIONS
Take only by mouth. Doses may be taken as a single daily dose or in
divided doses.
take 1-3
adults and children
12 years and over
take 1-3
capsules
daily
children 2 to under
12 years of age
take 1
capsules
daily
children under 2
years
ask a doctor
OTHER INFORMATION
EACH CAPSULE CONTAINS: sodium 6 mg
store at 25°C (77°F)); excursions permitted between 15°-30°C
(59°-86°F)
INACTIVE INGREDIENTS
FD&C Red No. 40, FD&C Yellow No. 6, edible ink, gelatin, glycerin,
polyethylene blycol, propylene
glycol, purified water and sorbitol special
QUESTIONS OR COMMENTS?
Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive,
Livonia, MI 48150, U.S.A.
call toll free 734-743-6000
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Original--07/2010--NJW
PACKAGE LABEL
BLISTER OF 60 CAPSULES
DOCUSATE SODIUM
docusate s