STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled 
Major Pharmaceuticals

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Drug Facts

Active ingredient (in each softgel)

 Docusate sodium 250 mg

Purpose

 Stool softener laxative

Uses

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

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 (1-800-222-1222) right away.

Directions

Other information

Inactive Ingredients

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink 

Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Extra Strength

Docusate Sodium

250 mg

Stool Softener Laxative

Softgels

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR PHARMACEUTICALS

Indianapolis, IN 46268

www.majorpharmaceuticals.com

Product Label

Docusate Sodium 250 mg

MAJOR Extra Strength Stool Softener Laxative

STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7281
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MANNITOL (UNII: 3OWL53L36A)  
MINERAL OIL (UNII: T5L8T28FGP)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
Colororange (Clear) Scoreno score
ShapeCAPSULESize20mm
FlavorImprint Code P4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7281-801000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2022
2NDC:0904-7281-60100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00710/14/2022
Labeler - Major Pharmaceuticals (191427277)

Revised: 4/2024
Document Id: 1e2b34bd-36f7-46a7-a565-a528c637c0e0
Set id: 93ef6486-0930-41e3-a2c6-44af7e37e98b
Version: 3
Effective Time: 20240411
 
Major Pharmaceuticals