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:

Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Stool softener laxative - for temporary relief of occasional constipation and irregularity  - this product generally produces bowel movement in 12 to 72 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

STOOL SOFTENER- DOCUSATE SODIUM CAPSULE, LIQUID FILLED
DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)
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DRUG FACTS
ACTIVE INGREDIENT (IN EACH SOFTGEL)
Docusate sodium 100 mg
PURPOSE
Stool softener laxative
USES
for temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 12 to 72 hours
WARNINGS
DO NOT USE
if you are presently taking mineral oil, unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts more than 2 weeks
STOP USE AND ASK A DOCTOR IF
you have rectal bleeding or no bowel movement after using a laxative.
These could be
sign 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 (188-222-
1222) right away
DIRECTIONS
take with a glass of water
adults and children 12
years and over
take 1 to 3 softgels daily. This dose may be taken as a single
daily dose or in divided doses.
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 7 mg
store at 25ºC (77º); excursions permitted between 15-30ºC
(59º-86ºF)
INACTIVE INGREDIENTS
citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin,
polyethylene glycol,
propylene glycol, purified water, sorbitol special, white edible ink
QUESTIONS OR COMMENTS?
CaLL toll free 1-866-4-REXALL
PRINCIPAL DISPLAY PANEL
STOOL SOFTENER
Docusate Sodium 100 mg
Stool softener laxative
Stimulant-free
Softgels
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS
BROKEN OR MISSING
DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
PRODUCT LABEL
REXALL STOOL SOFTENER
STOOL SOFTENER
docusate sodium capsule, liquid filled
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:55910-939(NDC:53345-008)
ROUTE OF ADMINISTRATI