DOCUSATE SODIUM LIQUID- docusate sodium liquid 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

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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Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softener

Uses

Relief of occasional constipation

Warnings

Do not use when

Ask a doctore before use if you

Stop use and ask doctor if

If pregnant or breast-feeding, ask a doctor before use

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

Directions

1 teasponnful = 5 mL

 Age Dose
 Adults and children over 12 years of age 1 to 6 teaspoons (50 mg - 300 mg)
 Children under 12 years of age Ask a doctor

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose

Questions or comments? 1-866-595-5598

DocusateSodium

DOCUSATE SODIUM LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54859-813
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLOXAMER 124 (UNII: 1S66E28KXA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54859-813-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/01/2021
Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)

Revised: 12/2021
Document Id: 0a7003c3-ab45-4797-8b98-44dba7314f33
Set id: 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c
Version: 1
Effective Time: 20211212
 
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION