SENNA/DOCUSATE SODIUM- docusate sodium and 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:

Physicians Total Care, Inc.

INN (International Name):

Docusate sodium

Composition:

Docusate sodium 50 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- relieves occasional constipation (irregularity) - generally causes bowel movement in 6 to 12 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

SENNA/DOCUSATE SODIUM - DOCUSATE SODIUM AND SENNOSIDES TABLET, FILM
COATED
PHYSICIANS TOTAL CARE, INC.
_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._
----------
SENNA-S
TAMPER-EVIDENT: Do not use this product if imprinted foil seal over
the mouth of the bottle is cut,
torn, broken or missing.
_DRUG FACTS_
_ACTIVE INGREDIENTS_
_(IN EACH TABLET)_
_PURPOSES_
Docusate sodium 50 mg
Stool softener
Sennosides 8.6 mg
Stimulant laxative
_PURPOSES_
Docusate sodium 50 mg
Stool softener
Sennosides 8.6 mg
Stimulant laxative
US ES
relieves occasional constipation (irregularity)
generally causes bowel movement in 6 to 12 hours
WARNINGS
DO NOT USE
this product if you are presently taking mineral oil, unless directed
by a doctor
laxative products for longer than 1 week unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
stomach pain
nausea
vomiting
a sudden change in bowel habits that persists over 2 weeks
STOP USE AND ASK A DOCTOR IF you
have rectal bleeding
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 overodse, get medical help
or contact a Poison Control
Center right away.
DIRECTIONS
take preferably at bedtime or as directed by a doctor
if you do not have a comfortable bowel movement by the second day,
increase dose by one tablet
(do not exceed maximum dosage) or decrease dose until you are
comfortable
AGE
STARTING DOSAGE
MAXIMUM
DOS AGE
adults and children 12
years and older
2 tablets once a
day
4 tablets twice a
day
children 6 to under 12
years
1 tablet once a day
2 tablets twice a
day
children 2 to under 6
years
1/2 tablet once a
day
1 tablet twice a
day
children under 2 years
ask a doctor
ask a doctor
OTHER INFORMATION
EACH TABLET CONTAINS: calcium 20 mg, sodium 6 mg (LOW SODIUM)
store at roo