SENNA LAXATIVE- sennosides tablet, coated

Senna Laxative by

Drug Labeling and Warnings

Senna Laxative by is a Otc medication manufactured, distributed, or labeled by NCS HealthCare of KY, Inc dba Vangard Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Sennosides 8.6mg 

Purpose

 Laxative

Uses

Relieves  occasional constipation (irregularity)

Generally causes 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 movements 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 perferably at bedtime or as directed by a doctor

If you do not have a comforable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comforable.

age		starting dosage			maximum dosage
adults and children over 12 years		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, sodium 2mg, VERY LOW SODIUM

store at 25ºC (77ºF) excursions permitted between 15º - 30ºC (59º - 86ºF)

Inactive ingredients

Croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions

To Report Adverse Drug Event Call: (800) 616-2471 

Distributed by MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150

Principal Display Panel

 Senna Tablets

INGREDIENTS AND APPEARANCE

SENNA LAXATIVE 
sennosides tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0615-4529(NDC: 0904-5165)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	BROWN	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	TCL;080
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0615-4529-31	31 in 1 BLISTER PACK
2	NDC: 0615-4529-39	30 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	05/04/2011

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)

Establishment
Name	Address	ID/FEI	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL(0615-4529) , REPACK(0615-4529)