DOCUSATE SODIUM- docusate sodium liquid 
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

Drug Facts

Active ingredient (in each 5 mL)

Docusate sodium 50 mg

Purpose

Stool softener

Uses

Warnings

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts 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 stool softener laxative for more than 1 week
  • rash occurs

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

adults and children 12 years and older5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 yearsask a doctor

Other information

NDC 0904-7279-66: 10 mL unit dose cup, in a tray of ten cups.

Inactive ingredients

artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.

Questions or comments?

Call 1-800-845-8210

R06/22

Distributed by:

MAJOR ® PHARMACEUTICALS 

Indianapolis, IN 46268

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

NDC 0904-7279-66

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Delivers 10 mL

See insert

For Institutional Use Only

MAJOR ® PHARMACEUTICALS

Indianapolis, IN 46268

F0935C100622

PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding

DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7279
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM50 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
Product Characteristics
Colorpink (Clear pink to purple-pink) Score    
ShapeSize
FlavorCHERRY (Cherry-Vanilla) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7279-7210 in 1 CASE12/05/2022
110 in 1 TRAY
1NDC:0904-7279-6610 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/16/2021
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693manufacture(0904-7279, 0904-7279)

Revised: 12/2022
Document Id: ef54be19-9474-7555-e053-2995a90af217
Set id: 1541ff5b-11f8-444b-a2a0-8e3086ae650a
Version: 3
Effective Time: 20221208
 
Major Pharmaceuticals