DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE- 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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Docusate Sodium - Stool Softener Laxative

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

• for relief of occasional constipation (irregularity)
• This generally produces a bowel movement within 12 to 72 hours.

Warnings

Ask a doctor before use if you have
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days

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 no bowel movement after using this product.
These can 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 care professional before use.

Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• take softgels with a full glass (8 oz) of water

adults and children 12 years of age and oldertake 1 to 3 softgels daily or as directed
by a doctor. This dose may be taken as a single daily dose or in divided doses.
children 6 to under 12 years of agetake 1 softgel daily or as directed by a doctor
children under 6 years of ageask a doctor

Other information

each softgel contains: sodium 10 mg (very low sodium)
• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).

Inactive ingredients

edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments? 

(800)616-2471

MAJOR®

Unit Dose

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by:
MAJOR® PHARMACEUTICALS
Livonia, MI 48152

Product of UAE
Packaged and Quality Assured in the USA

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Packaging

Major1

DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7183
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (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
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code 777
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7183-6110 in 1 CARTON09/04/2021
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/04/2021
Labeler - Major Pharmaceuticals (191427277)

Revised: 7/2023
Document Id: ca84ae13-c056-4f57-845b-fd26f2ebd3aa
Set id: cc8d1556-f108-4166-837c-48f81152877e
Version: 2
Effective Time: 20230725
 
Major Pharmaceuticals