Stool Softener plus Laxative by QUALITY CHOICE (Chain Drug Marketing Association) DRUG FACTS

Stool Softener plus Laxative by

Drug Labeling and Warnings

Stool Softener plus Laxative 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]

STOOL SOFTENER PLUS LAXATIVE- docusate sodium sennosides tablet 
QUALITY CHOICE (Chain Drug Marketing Association)

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.

----------

DRUG FACTS

Active Ingredients (in each tablet)

Docusate Sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool softener

Laxative

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 continues over a period of 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 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 preferably at bedtime or as directed by a doctor

age	starting dosage	maximum dosage
adults and children 12 years of age and 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 30 mg
• each tablet contains: sodium 6 mg LOW SODIUM
• store at 25ºC (77º); 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 red #40 aluminum lake*, FD&C yellow #6 aluminum lake, hypromellose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon 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 Senokot-S®

Stool Softener plus laxative

Stool Softener Laxative

Docusate Sodium, 50 mg | Sennosides, 8.6 mg

Provides Gentle Relief of: Occasional Constipation

Tablet

**This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W. 9 Mile Rd

Novi, MI 48376

www.qualitychoice.com

Product Label

QUALITY CHOICE Stool Softener

STOOL SOFTENER PLUS LAXATIVE 
docusate sodium sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-874
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
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)
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)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL081;PSD21;S35
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-874-60	1 in 1 BOX	01/31/2019	04/30/2025
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	01/31/2019	04/30/2025

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

Revised: 5/2023

Document Id: c539cb1c-64cf-4106-a89c-9555f2a76a8a

34390-5

Set id: da85418c-bf37-42b7-874f-3a2318d0863c

Version: 3

Effective Time: 20230511

 

QUALITY C