DOCUSATE SODIUM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 100 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

DOCUSATE SODIUM- DOCUSATE SODIUM CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
_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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DRUG FACTS
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Docusate Sodium 100 mg
PURPOS E
Stool softener laxative
US ES
relieves occasional constipation (irregularity)
generally produces 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 habits that last over 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 a
signs of a serious condition.
you need to use a laxative for more than 1 week
IF PREGNANT OR BREAST-FEEDING,
ask a health care 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.
adults and children 12 years of age and
over
take 1 to 3 softgels daily.
children 2 to under 12 years of age
take 1 softgel daily
children under 2 years of age
ask a doctor
OTHER INFORMATION
each softgel contains: SODIUM 7 MG
store at 25ºC (77ºF);excursions permitted between 15-30ºC
(59-86ºF)
INACTIVE INGREDIENTS
edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin,
medium-chain triglycerides*,
polyethylene glycol, propylene glycol*, purified water sorbitan,
sorbitol
*contains one or more of these ingredients
QUESTIONS OR COMMENTS?
Call 1-877-753-3935 MONDAY-FRIDAY 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
**Compare to the active ingredient in Colace®
DOK™ 100MG
Docusate sodium
Stool Softener
For Use as a Stool Softener in Treating & Avoiding Constipation
Softgels
**This product is not manufactured or d