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NDC 70518-2586-00 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 REMEDYREPACK INC.. 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: 70518-2586-00
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: 70518-2586-00
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	70518-2586
Product ID	70518-2586_d9df347d-fb0c-e045-e053-2a95a90ae115
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
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	REMEDYREPACK INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 70518-2586-00 (70518258600)

Pricing Information	N/A
NDC Package Code	70518-2586-0
Billing NDC	70518258600
Package	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2586-0)
Marketing Start Date	2020-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c8689a1a-4947-43b0-a859-85541ccf6d07 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 15-30 oC (59-86 oF)

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

DRUG: Stool Softener plus Stimulant Laxative

GENERIC: Docusate Sodium 50 mg and Sennosides 8.6 mg

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2586-0

NDC: 70518-2586-1

NDC: 70518-2586-2

COLOR: red

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: PH32

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

SENNOSIDES 8.6mg in 1
DOCUSATE SODIUM 50mg in 1

INACTIVE INGREDIENT(S):

CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C RED NO. 40
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM BENZOATE
TALC
TITANIUM DIOXIDE

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:70518-2586(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
Packaging
1	NDC:70518-2586-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	02/18/2020
2	NDC:70518-2586-1	100 in 1 BOX	03/09/2022
2	NDC:70518-2586-2	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	02/18/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 3/2022

Document Id: d9df347d-fb0c-e045-e053-2a95a90ae115

Set id: c8689a1a-4947-43b0-a859-85541ccf6d07

Version: 6

Effective Time: 20220310