SENNA PLUS- standardized senna concentrate and docusate sodium tablet, film coated

Active ingredient

Drug Facts

Active Ingredient (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg
Purpose

Stool Softener

Stimulant Laxative
Uses
- relieves occasional constipation
- generally produces a bowel movement within 6-12 hours
Warnings
Do not use
- if you are taking mineral oil
- for longer than one week
- when abdominal pain, nausea or vomiting are present
Ask a doctor before use if you have a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after use of this product.
These may indicate a serious condition.

If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children.

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
if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage)

age	starting dose	maximum dose
adults and children 12 years & over	2 tablets once daily	4 tablets twice daily
children 6 to under 12 years	1 tablet once daily	2 tablets twice daily
children 2 to under 6 years	1/2 tablet once daily	1 tablet twice daily
children under 2 years	ask a doctor	ask a doctor

Other Information
- each tablet contains: calcium 20 mg, sodium 6 mg (LOW SODIUM)
- store at 20º - 25ºC (68º - 77ºF)
Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystaline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide
Questions or comments?

(800) 616-2471
Distributed by

Distributed by

MAJOR® PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

Packaged by

Legacy Pharmaceutical Packaging, LLC

Earth City, MO 63045

Rev. 06/13
PRINCIPAL DISPLAY PANEL SENNA PLUS TABLETS, 8.6/50 MG

INGREDIENTS AND APPEARANCE

SENNA PLUS
standardized senna concentrate and docusate sodium tablet, film coated

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SENNOSIDES A AND B (UNII: 1B5FPI42EN) (SENNOSIDES A AND B - UNII:1B5FPI42EN)	SENNOSIDES A AND B	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 0904-6339-61	100 in 1 CARTON	01/14/2010	08/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug other		01/14/2010	08/31/2020

Labeler - Major Pharmaceuticals (191427277)

Senna Plus by