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NDC 54629-0600-99 Docusate Sodium 100 mg/1 Details

Docusate Sodium 100 mg/1

Docusate Sodium is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by National Vitamin Company. 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: 54629-0600-99
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	54629-0600
Product ID	54629-600_6786b7c4-5d1c-458a-ae03-819d4726dbba
Associated GPIs	46500010300110
GCN Sequence Number	003009
GCN Sequence Number Description	docusate sodium CAPSULE 100 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09101
HICL Sequence Number	001326
HICL Sequence Number Description	DOCUSATE SODIUM
Brand/Generic	Generic
Proprietary Name	Docusate Sodium
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	National Vitamin Company
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 54629-0600-99 (54629060099)

Pricing Information	N/A
NDC Package Code	54629-600-99
Billing NDC	54629060099
Package	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-600-99)
Marketing Start Date	2000-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 800fb383-3bb3-424a-a729-d9cd57a37a1e Details

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool Softener

Uses

•: For the relief of occasional constipation.
•: Helps to prevent dry, hard stools.
•: This product generally produces a bowel movement within 12 to 72 hours.

WARNINGS Do not use:

•: If you are currently taking mineral oil, unless directed by a doctor.
•: When abdominal pain, nausea, or vomiting are present.
•: For longer than one week unless directed by a doctor.

Ask a doctor before use

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Stop use and ask a doctor

if you have rectal bleeding or you fail to have a bowel movement after use.

If you are pregnant or breast-feeding,

ask a healthcare 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

Adults and Children over 12 years of age	Take orally 1 to 2 softgels preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children 6 to 12 years of age	Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
Children under 6 years of age	Do not use this product for children under 6 years of age, unless directed by a doctor.

Other Information

•: Each softgel contains 5 mg of Sodium.
•: Keep lid tightly closed.
•: Store at room temperature between 15°C to 30°C (59°F to 86°F).
•: Do not use if printed seal under cap is broken or missing.
•: For identification purposes, each softgel will have an imprint that reads NV13.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

Package/Label Principal Display Panel

NDC 54629-600-01

Life-Line®

DOCUSATE SODIUM, USP

STOOL SOFTENER

100 mg Each

100 Softgels

Manufactured and Distributed by

National Vitamin Company

Casa Grande, AZ 85122

Bottle Label

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54629-600
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	NV13
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54629-600-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000
2	NDC:54629-600-99	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2000

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	05/01/2000

Labeler - National Vitamin Company (102098324)

Name	Address	ID/FEI	Business Operations
Establishment
National Vitamin Company		102098324	MANUFACTURE(54629-600)

Name	Address	ID/FEI	Business Operations
Establishment
SWISSCAPS Romania srl		565466997	MANUFACTURE(54629-600)

Revised: 4/2020

Document Id: 6786b7c4-5d1c-458a-ae03-819d4726dbba

Set id: 800fb383-3bb3-424a-a729-d9cd57a37a1e

Version: 3

Effective Time: 20200410