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NDC 70000-0526-01 Stool Softener plus Stimulant Laxative 50; 8.6 mg/1; mg/1 Details

Stool Softener plus Stimulant Laxative 50; 8.6 mg/1; mg/1

Stool Softener plus Stimulant Laxative is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH, 110 DBA LEADER. 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: 70000-0526-01
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: 70000-0526-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	70000-0526
Product ID	70000-0526_5814ba2a-3485-4aec-b499-cb9e43aa1c08
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 plus Stimulant Laxative
Proprietary Name Suffix	n/a
Non-Proprietary Name	Docusate Sodium 50 mg and Sennosides 8.6 mg
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	50; 8.6
Active Ingredient Units	mg/1; mg/1
Substance Name	DOCUSATE SODIUM; SENNOSIDES
Labeler Name	CARDINAL HEALTH, 110 DBA LEADER
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0526-01 (70000052601)

Pricing Information
NDC Package Code	70000-0526-1
Billing NDC	70000052601
Package	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-1)
Marketing Start Date	2019-10-23
NDC Exclude Flag	N
Price Per Unit	0.02987
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	STOOL SOFTENER-STIM LAX TABLET
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

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 3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce Details

Active Ingredients (in each tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

relieves occasional constipation (irregularity)
generally produces a bowel movement in 6 to 12 hours

Warnings

Do 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 the use of a laxative.

These could be sings 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 (1-800-222-1222).

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 upto 1 tablet daily
children under 2	ask a doctor

Other information

each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PRINCIPAL DISPLAY PANEL

LEADER TM

NDC 70000-0526-1

Stool Softener +

Stimulant Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

COMPARE TO

COLACE® 2-IN-1

active ingredients*

100% Money

Back Guarantee

100 TABLETS

INGREDIENTS AND APPEARANCE

STOOL SOFTENER PLUS STIMULANT LAXATIVE

docusate sodium 50 mg and sennosides 8.6 mg tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0526
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND (ROUND TABLET)	Size	10mm
Flavor		Imprint Code	PH32
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0526-1	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/23/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/23/2019

Labeler - CARDINAL HEALTH, 110 DBA LEADER (063997360)

Registrant - Pharbest Pharmaceuticals, Inc. (557054835)

Name	Address	ID/FEI	Business Operations
Establishment
Pharbest Pharmaceuticals, Inc.		557054835	manufacture(70000-0526) , analysis(70000-0526) , pack(70000-0526) , label(70000-0526)

Revised: 6/2021

Document Id: 5814ba2a-3485-4aec-b499-cb9e43aa1c08

Set id: 3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce

Version: 2

Effective Time: 20210629