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NDC 71335-0294-02 Stool Softener 100 mg/1 Details

Stool Softener 100 mg/1

Stool Softener is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is DOCUSATE SODIUM.

MedlinePlus Drug Summary

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: 71335-0294-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	71335-0294
Product ID	71335-0294_2c9a1fe7-b77b-436b-8701-9f95f642d001
Associated GPIs	46500010300110
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	n/a
Non-Proprietary Name	Docusate Sodium
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, LIQUID FILLED
Route	ORAL
Active Ingredient Strength	100
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Bryant Ranch Prepack
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 71335-0294-02 (71335029402)

Pricing Information	N/A
NDC Package Code	71335-0294-2
Billing NDC	71335029402
Package	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-2)
Marketing Start Date	2018-02-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2c9a1fe7-b77b-436b-8701-9f95f642d001 Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

relieves occasional constipation (irregularity)

generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you

• have stomach pain, nausea or vomiting

• have a sudden change in bowel habits that persists over a period of 2 weeks

• are presently taking mineral oil

Stop use and ask a doctor if

• you need to use a laxative longer than 1 week

• you have rectal bleeding or fail to have a bowel movement. 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

• do not exceed recommended dose

• adults and children 12 years and older: take 1-3

softgels daily until first bowel movement; 1 softgel

daily thereafter, or as directed by a doctor

• children under 12: consult a doctor

Other information

• each softgel contains: sodium 7 mg. Very low sodium

• store at 59°-77°F (15°-25°C)

• keep tightly closed

• Tamper Evident: Do not use if imprinted seal

under cap is missing or broken.

Inactive ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerin, PEG, sorbitol special, water.

HOW SUPPLIED

NDC: 71335-0294-1: 30 Tablets in a BOTTLE

NDC: 71335-0294-2: 100 Tablets in a BOTTLE

NDC: 71335-0294-3: 60 Tablets in a BOTTLE

NDC: 71335-0294-4: 120 Tablets in a BOTTLE

NDC: 71335-0294-5: 90 Tablets in a BOTTLE

NDC: 71335-0294-6: 180 Tablets in a BOTTLE

NDC: 71335-0294-7: 10 Tablets in a BOTTLE

NDC: 71335-0294-8: 28 Tablets in a BOTTLE

NDC: 71335-0294-9: 56 Tablets in a BOTTLE

NDC: 71335-0294-0: 18 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Docusate Sodium 100mg Capsule

INGREDIENTS AND APPEARANCE

STOOL SOFTENER

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-0294(NDC:57896-401)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MANNITOL (UNII: 3OWL53L36A)

Product Characteristics
Color	red (reddish)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	SCU1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-0294-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	04/11/2018
2	NDC:71335-0294-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/27/2018
3	NDC:71335-0294-3	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2018
4	NDC:71335-0294-4	120 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
5	NDC:71335-0294-5	90 in 1 BOTTLE; Type 0: Not a Combination Product	05/23/2018
6	NDC:71335-0294-6	180 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
7	NDC:71335-0294-7	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
8	NDC:71335-0294-8	28 in 1 BOTTLE; Type 0: Not a Combination Product	09/20/2019
9	NDC:71335-0294-9	56 in 1 BOTTLE; Type 0: Not a Combination Product	02/09/2022
10	NDC:71335-0294-0	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/18/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2000

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-0294) , RELABEL(71335-0294)

Revised: 2/2022

Document Id: 2c9a1fe7-b77b-436b-8701-9f95f642d001

Set id: 2c9a1fe7-b77b-436b-8701-9f95f642d001

Version: 5

Effective Time: 20220209