SENNA tablet, film coated

SENNA by

Drug Labeling and Warnings

SENNA by is a Otc medication manufactured, distributed, or labeled by HIMPRIT PHARMACHEM PVT LTD, SPIRIT PHARMACEUTICALS,LLC, ELYSIUM PHARMACEUTICALS LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

• relieves occasional constipation (irregularity)
• generally produces a bowel movement in 6-12 hours

Warnings

Do not use

• 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 medial 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

Other information

• each tablet contains: calcium 25mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

PRINCIPAL DISPLAY PANEL - Shipping Label

Each Film Coated Tablet Contains :
CALCIUM SENNOSIDES 8.6mg

Lot No. :
Mfg. Date :
Exp. Date :
Jar No. :
Quantity : 50,000 Tablets
NDC No : 65437 - 087 - 50

WARNING :
KEEP OUT OF THE REACH OF CHILDREN

STORE AT CONTROLLED ROOM TEMPERATURE OF 59°-77°F (15°-25° C )
PROTECT FROM LIGHT, MOISTURE 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 FDA AND REGULATIONS THEREUNDER.

Manufactured By :
MANUFACTURER CODE No.: Guj/Drugs/G/1362
LABELER CODE # 14803

Manufactured For.
HIMPRIT PHARMACHEM PVT. LTD.
"LAKULESH", R.V. DESAI ROAD,
NEXT TO NAVAPURA POLICE STATION,
BARODA, INDIA - 390 001

CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

INGREDIENTS AND APPEARANCE

SENNA 
senna tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65437-087
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNA (UNII: AK7JF626KX) (SENNA - UNII:AK7JF626KX)	SENNA	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S8
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65437-087-50	1 in 1 DRUM
1		50000 in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part334	11/20/2009

Labeler - HIMPRIT PHARMACHEM PVT LTD (917261992)

Registrant - SPIRIT PHARMACEUTICALS,LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LTD		858352983	MANUFACTURE