COLACE- docusate sodium - sennosides tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG), SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)

Available from:

Atlantis Consumer Healthcare, Inc.

INN (International Name):

DOCUSATE SODIUM

Composition:

DOCUSATE SODIUM 50 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - relieves occasional constipation (irregularity) - generally produces bowel movement in 6 to 12 hours Warnings Do not use - laxative products for longer than 1 week unless told to do so by a doctor - if you are presently taking mineral oil, unless told to do so by a doctor 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.

Product summary:

Other information

Authorization status:

OTC monograph not final

Summary of Product characteristics

COLACE- DOCUSATE SODIUM - SENNOSIDES TABLET, FILM COATED
ATLANTIS CONSUMER HEALTHCARE, INC.
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_COLACE_
_DRUG FACTS_
_ACTIVE_
_INGREDIENT_
_PURPOSE_
Docusate
sodium 50 mg
Stool
softener
Sennosides 8.6
mg
Stimulant
laxative
_USES_
relieves occasional constipation (irregularity)
generally produces bowel movement in 6 to 12 hours
_WARNINGS_
DO NOT USE
laxative products for longer than 1 week unless told to do so by a
doctor
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 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.
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,
preferably in the
evening, or in divided doses.
adults and children 12
years and over
take 2-4 tablets
daily
children 6 to under 12
years of age
take 1-2 tablets
daily
children 2 to under 6
years of age
take up to 1
tablet daily
children under 2
ask a doctor
_OTHER INFORMATION_
each tablet contains: CALCIUM 7 MG, SODIUM 4 MG VERY LOW SODIUM
store at 25°C (77°F); excursions permitted between 15°-30°C
(59°-86°F).
Keep tightly closed..
_INACTIVE INGREDIENTS_
croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 Lake, FD&C
Red #40 Lake,
FD&C Yellow #6 Lake, hypromellose, magnesium stearate, maltodextrin,
microcrystalline
cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium
lauryl sulfate, starch,
stearic acid, talc, titanium dioxide, triacetin.
Dist. by: Atlantis Consumer Healthcare inc.
Bridgewater, NJ 08801 USA
Questions? 1-833-286-2684
©2023 Atlantis Consumer Healthcare inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.
A1023
R5250