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NDC 68210-3030-01 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 SPIRIT PHARMACEUTICALS LLC. 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: 68210-3030-01
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: 68210-3030-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	68210-3030
Product ID	68210-3030_ee1252cb-8320-7b66-e053-2995a90a21ae
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
Proprietary Name Suffix	WITH STIMULANT LAXATIVE
Non-Proprietary Name	DOCUSATE SODIUM, 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	SPIRIT PHARMACEUTICALS LLC
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 68210-3030-01 (68210303001)

Pricing Information	N/A
NDC Package Code	68210-3030-1
Billing NDC	68210303001
Package	100 TABLET in 1 BOTTLE (68210-3030-1)
Marketing Start Date	2018-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 74ffcb12-d94a-4250-a83b-ee6d20ab7409 Details

Drug Facts

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 bowel movement in 6-12 hours

SPL UNCLASSIFIED SECTION

Warnings

Do not use

■ laxative products for longer than 1 week unless directed by

a doctor

■ if you are presently 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 could be signs of a serious condition.

SPL UNCLASSIFIED SECTION

Drug Facts (continued)

If pregnant or breast-feeding,

ask a health professional before use.

SPL UNCLASSIFIED SECTION

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 up to 1 tablet daily
children under 2	ask a doctor

Other information

■ each tablet contains: calcium 20 mg, sodium 6 mg

■ store at 25°C (77°F); excursions permitted between

15°-30°C (59°-86°F)

Inactive ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium

phosphate, FD&C Red #40, hypermellose, magnesium

stearate, maltodextrin, microcrystalline cellulose, polyethylene

glycol-400, purified water, sodium benzoate, stearic acid,

titanium dioxide

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

COMPARE TO THE ACTIVE

INGREDIENTS OF PERI-COLACE®†

FAMILY WELNESS

Stool Softener

with Stimulant Laxative

Docusate Sodium 50 mg

Sennosides 8.6 mg

Relieves

Constipation

ACTUAL SIZE

100 TABLETS

INGREDIENTS AND APPEARANCE

STOOL SOFTENER WITH STIMULANT LAXATIVE

docusate sodium, sennosides tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68210-3030
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
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	S44
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68210-3030-1	100 in 1 BOTTLE; Type 0: Not a Combination Product	12/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/01/2018

Labeler - SPIRIT PHARMACEUTICALS LLC (179621011)

Revised: 11/2022

Document Id: ee1252cb-8320-7b66-e053-2995a90a21ae

Set id: 74ffcb12-d94a-4250-a83b-ee6d20ab7409

Version: 4

Effective Time: 20221122

Search by Drug Name or NDC

NDC 68210-3030-01 STOOL SOFTENER 50; 8.6 mg/1; mg/1 Details

STOOL SOFTENER 50; 8.6 mg/1; mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 68210-3030-01 (68210303001)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 74ffcb12-d94a-4250-a83b-ee6d20ab7409 Details

Drug Facts

Active ingredients (in each tablet)

Purpose

Uses

SPL UNCLASSIFIED SECTION

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

If pregnant or breast-feeding,

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

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