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NDC 00904-7115-61 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 Major Pharmaceuticals. 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: 00904-7115-61
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Stool Softeners

Product Information

NDC	00904-7115
Product ID	0904-7115_100f18be-911a-4a77-9b5d-2ff48dd3c4ce
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	Major Pharmaceuticals
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 00904-7115-61 (00904711561)

Pricing Information
NDC Package Code	0904-7115-61
Billing NDC	00904711561
Package	10 BLISTER PACK in 1 CARTON (0904-7115-61) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date	2021-04-16
NDC Exclude Flag	N
Price Per Unit	0.02259
Pricing Unit	EA
Effective Date	2022-10-19
NDC Description	DOCUSATE SODIUM 100 MG SOFTGEL
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2022-11-02

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 4419de58-79bf-4ab7-93e5-5eea8603839b Details

Active ingredient (in each liquid-filled capsule)

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
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

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.
you need to use a laxative for more than 1 week

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 take more than directed
take with a glass of water
take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1 to 3 capsules daily
children 2 to under 12 years	take 1 capsule daily
children under 2 years	ask a doctor

Other information

each capsule contains: sodium 8 mg

Very Low Sodium
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from light, heat and moisture
TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
see end flap for expiration date and lot number

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, white ink

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

NDC 0904-7115-61

Unit Dose

Docusate Sodium

Stool Softener Laxative

100 mg

This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

100 Softgels

50844 ORG112075212

Distributed by:

MAJOR® PHARMACEUTICALS

Livonia, MI 48152

Product of Dubai

Packaged and Quality Assured in the USA

Rev. 02/21 M-17 Re-order No. 701287

Major 44-752

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM

docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-7115
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 (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red (clear)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	752
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-7115-61	10 in 1 CARTON	04/16/2021
1		10 in 1 BLISTER PACK; 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	04/16/2021

Labeler - Major Pharmaceuticals (191427277)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0904-7115)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0904-7115)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0904-7115)

Revised: 4/2022

Document Id: 100f18be-911a-4a77-9b5d-2ff48dd3c4ce

Set id: 4419de58-79bf-4ab7-93e5-5eea8603839b

Version: 3

Effective Time: 20220419