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NDC 48433-0101-01 Docusate Sodium 250 mg/1 Details

Docusate Sodium 250 mg/1

Docusate Sodium is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by Safecor Health, LLC. 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: 48433-0101-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	48433-0101
Product ID	48433-101_3c42dd05-b2d9-411b-8ef2-63baa98ebe3b
Associated GPIs	46500010300120
GCN Sequence Number	003011
GCN Sequence Number Description	docusate sodium CAPSULE 250 MG ORAL
HIC3	D6S
HIC3 Description	LAXATIVES AND CATHARTICS
GCN	09102
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	250
Active Ingredient Units	mg/1
Substance Name	DOCUSATE SODIUM
Labeler Name	Safecor Health, LLC
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 48433-0101-01 (48433010101)

Pricing Information	N/A
NDC Package Code	48433-101-01
Billing NDC	48433010101
Package	100 CAPSULE, LIQUID FILLED in 1 BOX, UNIT-DOSE (48433-101-01)
Marketing Start Date	2000-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a2586a38-4e2c-4244-8618-0b614d585605 Details

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Directions

Adults and Children over 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 12 years of age	Do not use this product for children under 12 years of age, unless directed by a doctor.

Other Information

•: Each softgel contains 13 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 NV12.

Inactive ingredients

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

Questions

Call 1 (800) 447-1006

Package/Label Principal Display Panel

Safecor Health

Docusate Sodium, USP

250 mg Each

NDC 48433-101-01

100 Unit Dose Softgels

Packaged and Distributed by:

Safecor Health, LLC

Columbus, OH 43204

Docusate soldium 250 mg Unit Dose Box Label

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48433-101(NDC:54629-601)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (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	20mm
Flavor		Imprint Code	NV12
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:48433-101-01	100 in 1 BOX, UNIT-DOSE; 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 - Safecor Health, LLC (828269675)

Name	Address	ID/FEI	Business Operations
Establishment
Safecor Health, LLC		078805287	REPACK(48433-101)

Revised: 1/2022

Document Id: 3c42dd05-b2d9-411b-8ef2-63baa98ebe3b

Set id: a2586a38-4e2c-4244-8618-0b614d585605

Version: 3

Effective Time: 20220126