DOCUSATE SODIUM- docusate sodium capsule, liquid filled
Major Pharmaceuticals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Major 44-752 Delisted

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

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	Marketing End Date
Packaging
1	NDC:0904-7115-61	10 in 1 CARTON	04/16/2021	08/13/2023
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	08/13/2023

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: 5/2023

Document Id: 00bf0cec-41b6-4e32-b2cc-e9f9092ec4d5

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

Version: 4

Effective Time: 20230518

Major Pharmaceuticals