SENNA-S- sennosides and docusate sodium tablet, film coated

Senna-S by

Drug Labeling and Warnings

Senna-S by is a Otc medication manufactured, distributed, or labeled by Kinray Inc., Pharbest Pharmaceuticals Inc., Pharbest Pharmaceutical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Sennosides from Senna Concentrate 8.6 mg

Sodium Dioctylsulfosuccinate 50 mg

Purposes

Sennosides from Senna Concentrate 8.6 mg...........Laxative
Sodium Dioctylsulfosuccinate 50 mg......................Stool Softener

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
• if you are now taking mineral oil, 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 and over	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 20 mg, sodium 6mg Low Sodium
• store at room temperature between 15-300C (59-860F)

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapoica starch, tartaric acid, titanium dioxide

Questions? Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SENNA-S 
sennosides and docusate sodium tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-019
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SENNOSIDES (UNII: 3FYP5M0IJX) (SENNOSIDES - UNII:3FYP5M0IJX)	SENNOSIDES	8.6 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, TAPIOCA (UNII: 24SC3U704I)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (orange)	Score	no score
Shape	ROUND (round shape)	Size	10mm
Flavor		Imprint Code	S90
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-019-60	1 in 1 CARTON
1		60 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	05/10/2011

Labeler - Kinray Inc. (012574513)

Registrant - Pharbest Pharmaceuticals Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceutical Inc.		557054835	repack(61715-019) , relabel(61715-019)