Drug Facts

Active ingredients (in each tablet)	Purpose
Docusate sodium 50 mg	Stool softener
Sennosides 8.6 mg	Laxative

Uses

relieves occasional constipation (irregularity)
generally produces a 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 indicate 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 preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age or 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

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, sodium benzoate, stearic acid, tartaric acid, titanium dioxide

PRINCIPAL DISPLAY PANEL - Shipping Label

SENNA 8.6mg & DOCUSATE SODIUM 50mg
Orange Tablets
Each Tablet Contains:
CALCIUM SENNOSIDES 8.6mg
DOCUSATE SODIUM 50mg

Lot No:	Quantity:
Mfg Date:	Jar No:
Exp Date:	NDC NO: 65437-035-50

WARNING:
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59 - 77 F (15 - 25 C)
PROTECT FROM LIGHT,MOISURE AND FREEZING.

THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT
CONFORMANCE WITH THE F.D. & C. ACT AND REGULATIONS THEREUNDER.

MANUFACTURED BY:
MANUFACTURED CODE NO Guj/Drugs/G/1362
LABELLER CODE # 14803

MANUFACTURED FOR:
HIMPRIT PHARMACHEM PVT.LTD.
"LAKULISH" R.V.DESAI ROAD
NEXT TO NAVAPURA POLICE STATION
BARODA, INDIA 390 001

PRINCIPAL DISPLAY PANEL - Shipping Label

SENNA LEAF AND DOCUSATE SODIUM
senna leaf and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65437-035
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE (UNII: 3NXW29V3WO)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:65437-035-50	1 in 1 DRUM
1		50000 in 1 BAG
2	NDC:65437-035-70	1 in 1 DRUM
2		75000 in 1 BAG

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	04/01/2010

Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)