SENNA-S- sennosides 8.6mg and docusate sodium 50mg 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 ingredient (in each tablet)

Sennosides from Senna Concentrate 8.6 mg

Docusate sodium 50 mg

Purpose

Laxative
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 
• you 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 immediately.

Directions

• take preferably at bedtime or as directed by a doctor
• Adults and children 12 years and over: 2 tablets once a day; maximum 4 tablets twice a day
• Children 6 to 12 years of age: 1 tablet once a day; maximum 2 tablets twice a day
• Children 2 to under 6 years: 1/2 tablet once a day; maximum 1 tablet twice a day
• Children under 2 years of age: ask a doctor

Other information

• each tablet contains 8 mg of Calcium, 3 mg Sodium, Very Low Sodium
• Store at controlled room temperature 150-300C (590-860F)

Inactive ingredients

Croscarmellose sodium, D&C Yellow #10, dicalcium phosphate, FD&C Yellow #6 , magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc & titanium dioxide.

Questions?

Adverse drug event call: (866) 562-2756

PRINCIPAL DISPLAY PANEL

Preferred plus PharmacyTM

NDC: 61715-149-60

60 Tablets

Senna-S

(standard senna concentrate

plus docusate sodium)

Gentle Natural

Vegetable Laxative

Compare to the Active Ingredients in Senokot-S®†

INGREDIENTS AND APPEARANCE

SENNA-S 
sennosides 8.6mg and docusate sodium 50mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-149
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (ORANGE COLOR)	Score	no score
Shape	ROUND (round shape)	Size	10mm
Flavor		Imprint Code	PH32
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-149-60	1 in 1 CARTON	08/01/2018
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/01/2018

Labeler - Kinray Inc. (012574513)

Registrant - Pharbest Pharmaceuticals Inc. (557054835)

Establishment
Name	Address	ID/FEI	Business Operations
Pharbest Pharmaceutical Inc.		557054835	analysis(61715-149) , manufacture(61715-149) , repack(61715-149)