STOOL SOFTENER- docusate sodium tablet 
STRATEGIC SOURCING SERVICES LLC

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sun 421

Active ingredient

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Uses

Warnings

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

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

cellulose, croscarmellose sodium, dicalcium phosphate, magnesium stearate, silica, stearic acid, talc

PACKAGE LABEL

1

STOOL SOFTENER 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-167
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code GC422
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-167-101 in 1 CARTON03/01/2016
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00703/01/2016
Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
Registrant - GCP Laboratories (965480861)
Establishment
NameAddressID/FEIBusiness Operations
GCP Laboratories965480861manufacture(49348-167)

Revised: 10/2023
Document Id: 08665d14-be97-d6d0-e063-6394a90a5781
Set id: 3ec5faa4-ff42-0862-e054-00144ff8d46c
Version: 5
Effective Time: 20231023
 
STRATEGIC SOURCING SERVICES LLC