DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Spirit Pharmaceuticals 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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VALUMEDS STOOL SOFTENER

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg 

Purpose

Stool Softner laxative

Uses

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Stop use and ask a doctor if you

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.1(800)222-1222

Directions

take with a glass of water

Adults and children 12 years and over

1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses

Children 2 to under 12 years of age

1 softgel daily.

Children under 2 years of age

Ask a doctor

Other information

Inactive ingredients

FD&C Red#40, FD&C Yellow#6, gelatin,glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL-
Valumeds Stool Softener 30 softels Bottle Labels-Single Tone

VALUMEDS TM

Compare to the active ingredient in

Dulcolax  ® Stool Softener  *

STOOL  SOFTENER

DOCUSATE SODIUM 100 mg

Gentle,Stimulant-Free Relief
Constipation Relief

30 SOFTGELS

Docusate sodium-Single Tone

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0317
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
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code 125
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68210-0317-31 in 1 CARTON04/10/2018
130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33404/10/2018
Labeler - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIBusiness Operations
MEDGEL PRIVATE LIMITED677385498manufacture(68210-0317)

Revised: 1/2022
Document Id: d57c80e1-84df-5986-e053-2a95a90a0b60
Set id: 5ebc8cbc-b896-405f-8a23-14bcd0a70353
Version: 4
Effective Time: 20220113
 
Spirit Pharmaceuticals LLC