TOPCARE STOOL SOFTENER- 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:

TOPCO ASSOCIATES LLC

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

TOPCARE STOOL SOFTENER- DOCUSATE SODIUM CAPSULE, LIQUID FILLED
TOPCO ASSOCIATES LLC
_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 100MG TWO-TONE, CAPSULE, LIQUID FILLED
DRUG FACTS
ACTIVE INGREDIENT (IN EACH SOFTGEL)
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 lasts 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 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
DIRECTIONS
Take only by mouth. Doses may be taken as a single daily dose or in
divided doses.
adults and children 12
years and over
take 1 to 3 softgels daily
children 2 to under 12
years of age
take 1 softgel daily
children under 2
years
ask a doctor
OTHER INFORMATION
each softgel contains: SODIUM 5 MG
VERY LOW SODIUM
store at room temperature 15°-30°C (59°-86°F) and avoid excessive
heat
INACTIVE INGREDIENTS
D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerol,
Polyethylene
glycol, purified water, sorbitol, titanium dioxide
DISPLAY PANEL
DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO RSEA0621
QUESTIONS? 1-888-423-0139 [e-mail] www.topcarebrand.com
TOPCARE STOOL SOFTENER
docusate sodium capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:7