SENNA-S- senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated

SENNA-S by

Drug Labeling and Warnings

SENNA-S by is a Otc medication manufactured, distributed, or labeled by HealthLife of USA LLC, Elysium Pharmaceutical Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients Purpose (in each tablet)          Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

Uses

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

Warnings

Do not use

• if you are now taking mineral oil, unless directed by a doctor
• 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 lasts over 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

• adults and children 12 years of age or older - starting dosage: 2 tablets once a day, maximum dosage: 4 tablets twice a day
• children 6 to under 12 years - starting dosage: 1 tablet once a day, maximum dosage: 2 tablets twice a day
• children 2 to under 6 years - starting dosage: 1/2 tablet once a day, maximum dosage: 1 tablet twice a day
• children under 2 years - starting dosage: ask a doctor, maximum dosage: ask a doctor

Other information

• each tablet contains: calcium 21 mg
• each tablet contains: sodium 3 mg VERY LOW SODIUM
• store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
• read all product information before using
• TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Senokot-S®

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg

INGREDIENTS AND APPEARANCE

SENNA-S 
senna and docusate sodium tablets, 8.6 mg and 50 mg tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-131
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	S35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-131-25	25 in 1 BOX	04/08/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69517-131-50	50 in 1 BOX	04/08/2016
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 69517-131-02	2 in 1 POUCH	04/08/2016
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 69517-131-10	1000 in 1 BOTTLE	04/08/2016
4	NDC: 69517-131-05	500 in 1 BOTTLE
4	NDC: 69517-131-24	24 in 1 BOTTLE
4		1 in 1 CARTON; 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	03/07/2016

Labeler - HealthLife of USA LLC (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceutical Ltd.		915664486	manufacture(69517-131)