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Senna-S

Dosage form: tablet, coated
Ingredients: DOCUSATE SODIUM 50mg, SENNOSIDES 8.6mg
Labeler: Avema Pharma Solutions
NDC code: 63548-4001

Drug Facts

Active ingredients (in each tablet)

Docusate Sodium 50 mg*

Sennosides 8.6 mg**

Purpose

*Stool softener

**Laxative

Uses

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

Warnings

Do not use

if you are now 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
noticed a sudden change in bowel habits that continues over a period of 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 may be signs of a serious condition.

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 right away.

Directions

take preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age and older	2 tablets once a day	4 tablets twice a day
children 6 to under 12 years of age	1 tablet once a day	2 tablets twice a day
children 2 to 6 years of age	½ tablet once a day	1 tablet twice a day
children under 2 years of age	ask a doctor	ask a doctor

Other information

each tablet contains: sodium 6 mg/tablet VERY LOW SODIUM
each tablet contains: calcium 20 mg/tablet
store at 15°-30°C (59°-86°F) in well closed containers
do not use if imprinted safety seal under cap is broken or missing
*This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Senokot-S®.

Inactive ingredients

carnauba wax, colloidal silicon dioxide,croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 8000, sodium benzoate, stearic acid, and titanium dioxide. May also contain: maltodextrin, mineral oil, Opadry II Orange, pregelatinized starch, talc, silicon dioxide 50s.

Package/Label Principal Display Panel

NDC 63548-4000-*1

NATURAL LAXATIVE

PLUS STOOL SOFTENER

SENNA-S

DOCUSATE SODIUM, 50 MG

AND SENNOSIDES, 8.6 MG

30 TABLETS

Do not use if imprinted safety seal under cap is broken or missing.

SENNA-S
docusate sodium and sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63548-4001
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	50 mg
SENNOSIDES (SENNOSIDES)	SENNOSIDES	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 6
D&C YELLOW NO. 10
HYPROMELLOSE
MAGNESIUM STEARATE
MALTODEXTRIN
MEDIUM-CHAIN TRIGLYCERIDES
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
STEARIC ACID
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:63548-4001-1	30 TABLET, COATED (TABLET) in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		01/02/2010

Labeler - Avema Pharma Solutions (804087749)

Revised: 02/2010

Document Id: 27ed056c-ec07-4269-9883-1f856c338aca

Set id: 27ed056c-ec07-4269-9883-1f856c338aca

Version: 1

Effective Time: 20100205

Avema Pharma Solutions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer