DOCUSATE SODIUM LIQUID- docusate sodium liquid 
Geritrex LLC

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 Liquid

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 over1 to 6 teaspoons (50 to 300 mg)
Children 2 to 12 years of age1 to 3 teaspoons (50 to 150 mg)

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, methylparaben, parabens, poloxamer, polyethylene glycol 400, propylparaben, sodium citrate, sorbitol, sucrose, and water.

image description

DOCUSATE SODIUM LIQUID 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-195
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)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
sodium citrate (UNII: 1Q73Q2JULR)  
water (UNII: 059QF0KO0R)  
Poloxamer 407 (UNII: TUF2IVW3M2)  
SUCROSE (UNII: C151H8M554)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-195-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/28/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/28/2017
Labeler - Geritrex LLC (112796248)
Registrant - RIJ Pharmaceutical Corporation (144679156)

Revised: 9/2017
Document Id: 6b770ed5-fd3f-4797-a693-6724b73c7758
Set id: 4d022ef5-fa76-4e50-b56b-759bc35754ab
Version: 1
Effective Time: 20170928
 
Geritrex LLC