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:

Major Pharmaceuticals

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
MAJOR PHARMACEUTICALS
_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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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)
Standardized Senna Concentrate, Sennosides 8.6 mg
Sodium Dioctylsulfosuccinate 50mg
PURPOS E
_PURPOSES_
Standardized Senna Concentrate, Sennosides 8.6 mg
laxative
Sodium Dioctylsulfosuccinate 50 mg
Stool softener
US ES
relieves occasional constipation (irregularity)
generally causes bowel movement in 6 to 12 hours
WARNINGS
DO NOT USE
laxative products for longer than 1 week unless directed by a doctor
if you are now taking mineral oil, unless directed by a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
nausea
vomiting
abdominal pain
a sudden change in bowel habits that persists over 2 weeks
STOP USE AND ASK A DOCTOR IF YOU HAVE
rectal bleeding or failure to have a bowel movement occurs 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 THE 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
AGE
STARTING DOSAGE
MAXIMUM DOSAGE
adults and children 12 years and older 2 tablets once a day 4 tablets
twice a day
6 to under 12 years
1 tablet once a day 2 tablets twice a day
children under 6 years
ask a doctor
ask a doctor
OTHER INFORMATION
Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º -
30ºC (59º - 86ºF). [See USP Controlled
Room Temperature]
OTHER INGREDIENTS
Croscarmellose Sodium, Dicalcium Phosphate, FD&C Yellow # 5 Lake**,
FD&C Yellow #6 Lake,
Hypromellose, Magnesium Silicate, Magnesium Stearate, Mi