SENNA S STOOL SOFTENER WITH LAXATIVE- docusate sodium, sennosides tablet
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredients (in each tablet)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
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

age	starting dosage	maximum dosage
adults and children 12 years of age or older	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
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake*, FD&C red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, maltodextrin*, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol*, purified water*, silicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5Pm EST

Principal Display Panel

**COMPARE TO THE ACTIVE INGREIDENTS IN SENOKOT-S®

Senna-S STOOL SOFTENER WITH LAXATIVE

DOCUSATE SODIUM 50 mg, SENNOSIDES 8.6 mg

Relieves Occasional Constipation

Tablets

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

DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC.

UPAR, Bldg. A3, Suite 338

1020 William Pitt Way, Pittsburgh, PA 15238

www.chaindrugconsortium.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Labeling

Premier Value Senna S Stool Softener with Laxative

SENNA S STOOL SOFTENER WITH LAXATIVE
docusate sodium, sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-206
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL081;SS1;S35
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-206-60	1 in 1 BOX	03/08/2013	03/08/2020
1		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	03/08/2013	03/08/2020

Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 6/2019

Document Id: 80c4a39a-5dc3-40f2-ab95-0b78564b69f1

Set id: 8d82634b-bbde-40b9-a694-24baa6615163

Version: 5

Effective Time: 20190626

Chain Drug Consortium, LLC