STOOL SOFTENER WITH LAXATIVE- docusate sodium and sennosides tablet

Stool Softener with Laxative by

Drug Labeling and Warnings

Stool Softener with Laxative by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener
Stimulant Laxative

Uses

• For overnight relief from occasional constipation (irregularity)
• generally produces a bowel movement in 6 to 12hours.

WarningsDo not use

• laxative products for longer than 1 week unless told to do so by a doctor.
• if you are presently taking mineral oil, unless told to do so 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 could be signs of a serious condition

If pregnant or breastfeeding

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 only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.

• adults and children 12 years and over: take 2-4 tablets daily
• children 6 to under 12 years of age: take 1-2 tablets daily
• children 2 to under 6 years of age: take up to 1 tablet daily
• children under 2: ask a doctor

Other information

• each tablet contains: calcium 20mg
• each tablet contains: sodium 6mg VERY LOW SODIUM
•  store at 15o - 30o C (59o-86o F), protect from excessive moisture

Inactive Ingredients

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

*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 ingredients in Peri- colace®

Stool Softener with laxative

Docusate Sodium 50 mg
Sennosides 8.6 mg

Distributed by:

CHAIN DRUG CONSORTIUM, LLC

3301 NW BOCA RATON BLVD. SUITE 101

BOCA RATON, FL 33431

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

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

Product Label

Docusate sodium and sennosides

INGREDIENTS AND APPEARANCE

STOOL SOFTENER WITH LAXATIVE 
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-002
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
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)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL97;SS2;S44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-002-01	1 in 1 BOX	07/08/2010	12/31/2020
1		100 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	07/08/2010	12/31/2020

Labeler - Chain Drug Consortium, LLC (101668460)