DOCUSATE SODIUM LIQUID- docusate sodium liquid 
Rij Pharmaceutical Corporation

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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Drug Facts

Active Ingredient (per teaspoonful = 5 mL)

Docusate Sodium 50 mg

Purpose

Stool Softener

Uses

Warnings

Do not use
Ask a doctor before use if you
Stop use and ask a doctor if

If pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions


Adults and children 12 years and over
1 to 4 teaspoons (50 to 200 mg)
Children under 12 years of age
ask a doctor

1 teaspoon = 5 mL


TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.


Other information

Inactive ingredients

citric acid, D&C Red #33, flavor, parabens, poloxamer, propylene glycol, sodium citrate, sorbitol, sucrose, and water.

Container Label

DOCUSATE SODIUM LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-216
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate sodium10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid (UNII: XF417D3PSL)  
D&C red no. 33 (UNII: 9DBA0SBB0L)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
propylene glycol (UNII: 6DC9Q167V3)  
sodium citrate (UNII: 1Q73Q2JULR)  
water (UNII: 059QF0KO0R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
SUCROSE (UNII: C151H8M554)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53807-216-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/1999
2NDC:53807-216-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/16/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33403/16/1999
Labeler - Rij Pharmaceutical Corporation (144679156)
Establishment
NameAddressID/FEIBusiness Operations
Rij Pharmaceutical Corporation144679156manufacture(53807-216)

Revised: 4/2018
Document Id: 27f1d997-9032-46d0-9caf-bc487d63bbea
Set id: c7978ca6-cc76-447b-b7bf-9547f6e49212
Version: 2
Effective Time: 20180430
 
Rij Pharmaceutical Corporation