DOCUSATE 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 A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)

Available from:

DIRECTRX

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

stool softner, laxative Uses: Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

Authorization status:

OTC monograph not final

Summary of Product characteristics

DOCUSATE SENNOSIDES- DOCUSATE SENNOSIDES TABLET, FILM COATED
DIRECTRX
REFERENCE LABEL SET ID: 835A2CD4-4801-3E40-E053-2A91AA0ABFEA
_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._
----------
DOCUSATE SENNOSIDES
Each Tablet contains:
Docustate sodium 50 mg
Sennosides 8.6 mg
INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide,
croscarmellose sodium, dibasic
calcium phosphate dihydrate, d-c yellow#10 aluminum lake fd&c yelow#6
aluminum lake,
hypromellose, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, sodium benzoate,
stearic acid, titanium dioxide
stool softner, laxative
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 (not to exceed
maximum dosage) or decrease
dose until you are comfortable.
Adults and children 12 years and over - starting dosage: 2 tablets
once a day maximum dosage: 4 tablets
twice a day
Children 6 to under 12 years - starting dosage: 1 tablet once a day
maximum dosage: 2 tablets twice a
day
Children to2 to under 6 years - starting dosage: 1/2 tablet once a day
maximum dosage: 1 tablet twice a
day
Children under 2 years - Ask a doctor
Uses:
Relieves occasional constipation (irregularity); generally causes
bowel movement in 6-12 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
keep out of the reach of children. In case of overdose, get medical
help or contact a Poison Control
Center right away.
DOCUSATE SENNOSIDES
docusate sennosides tablet, film coated
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 19 19 -771(NDC:49 48 3-0 8 1)
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DO CUSATE S