STOOL SOFTENER STIMULANT LAXATIVE- docusate sodium and sennosides tablet

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). 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 bowel movement in 6 to12 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 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 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 older: take 2-4 tablets daily
• childrens 6 to under 12 years of age: take1-2 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 30 mg
• each tablet contains: sodium 6 mg VERY LOW SODIUM
• store at 25ºC(77ºF), excursion permitted between 15-30ºC (59-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol*, sillicon dioxide, sodium benzoate*, stearic acid, talc*, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

**Compare to the Active Ingredients in Colace® 2-IN-1

STOOL SOFTENER

 Plus Stimulant Laxative

Docusate sodium, 50 mg

Sennosides, 8.6 mg

Effective

Reliable

Comfortable 

TABLETS

†This product is not manufactured or distributed by Avrio Health L.P., Distributor of Colace® 2-IN-1.

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

Distributed by C.D.M.A. Inc.©

43157 W. 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Product Label

QUALITY CHOICE Stool Softener Plus Stimulant Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER  STIMULANT LAXATIVE
docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-875
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 BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ALUMINUM OXIDE (UNII: LMI26O6933)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097;PSD21;S44
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-875-01	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/31/2018

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)