Search by Drug Name or NDC

NDC 63868-0135-10 Stool Softener 50; 8.6 mg/1; mg/1 Details

Stool Softener 50; 8.6 mg/1; mg/1

Stool Softener is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is DOCUSATE SODIUM; SENNOSIDES.

MedlinePlus Drug Summary

Senna is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Senna is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 63868-0135-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Senna

Stool softeners are used on a short-term basis to relieve constipation by people who should avoid straining during bowel movements because of heart conditions, hemorrhoids, and other problems. They work by softening stools to make them easier to pass.

Related Packages: 63868-0135-10
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	63868-0135
Product ID	63868-135_3db1b4d4-0073-41d6-a1ca-577a323da0d3
Associated GPIs	46991002770320
GCN Sequence Number	048044
GCN Sequence Number Description	sennosides/docusate sodium TABLET 8.6MG-50MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	13483
HICL Sequence Number	021772
HICL Sequence Number Description	SENNOSIDES/DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Stool Softener
Proprietary Name Suffix	Stimulant laxative
Non-Proprietary Name	docusate sodium and sennosides
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	50; 8.6
Active Ingredient Units	mg/1; mg/1
Substance Name	DOCUSATE SODIUM; SENNOSIDES
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	n/a

Package

Package Images

NDC 63868-0135-10 (63868013510)

Pricing Information
NDC Package Code	63868-135-10
Billing NDC	63868013510
Package	100 TABLET in 1 BOTTLE, PLASTIC (63868-135-10)
Marketing Start Date	2015-11-30
NDC Exclude Flag	N
Price Per Unit	0.03409
Pricing Unit	EA
Effective Date	2022-08-17
NDC Description	QC STOOL SOFTENER-LAXATIVE TAB
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-08-17

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 3430bf2e-c664-4e06-90f3-7fac86c38655 Details

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 told to do so by a doctor
if you are now 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 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 20 mg
each tablet contains: sodium 6 mg VERY LOW SODIUM
store at 25ºC(77ºF), protect from heat, light, and moisture

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, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, polyvinyl alcohol*, 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 Peri-Colace®

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 Purdue Products L.P., Distributor of Peri-Colace®.

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

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Docusate Sodium 50 mg, Sennosides 8.6 mg

Quality Choice Stool Softener Red Tablet

INGREDIENTS AND APPEARANCE

STOOL SOFTENER STIMULANT LAXATIVE

docusate sodium and sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-135
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)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
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)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL097;0806;AV;S44
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63868-135-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/30/2015	05/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	11/30/2015	05/31/2024

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

Revised: 11/2021

Document Id: 3db1b4d4-0073-41d6-a1ca-577a323da0d3

Set id: 3430bf2e-c664-4e06-90f3-7fac86c38655

Version: 4

Effective Time: 20211102