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DOCUSATE SODIUM by Spirit Pharmaceuticals LLC

Medically reviewed on April 11, 2018

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Spirit Pharmaceuticals LLC
NDC Code: 68210-0305

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.

VALUMEDS STOOL SOFTENER

Drug Facts

Active ingredient (in each gelcaps)

Docusate Sodium 100 mg 

Purpose

Stool Softner

Uses
  • for the prevention of the dry, hard stools
  • for relief of occassional constipation. This product generally produces a bowel movement within 12 to 72 hours

Do not use

if you are currently taking mineral oil, unless directed to so by a doctor.

When abdominal pain, nausea, or vomiting are present for longer than 1 week unless directed by a doctor

Ask a doctor before use if you

notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use abd ask a doctor if you

have rectal bleeding fail to have a bowel movement occur after use.

If pregnant or breast-feeding 

ask a health professional before use

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1(800)222-1222 immediately.

Stop use and ask a doctor if you

have rectal bleeding fail to have bowel movement occur after use.

If pregnant or breast feeding 

Ask a health professional before use 

Keep out of reach of children

In case of accidental overdose, get medical help or contact a Poison Control Center 1-800-222-1222 immediately.

Directions
  • adult and children 12 years and over: take 1-3 gelcaps, preferably at bedtime
  • children 2 to under 12 years of age: take 1 gelcap at bedtime
  • children under 2 years of age: ask a doctor

Other information
  • Store at room temperature 15-30°C  (59-86°F) 
  • do not use if safety seal under cap is torn or missing

Inactive ingredients

FD&C Red #33, FD&C Red#40, FD&C Yellow#6, gelatin,

glycerin, polyethylene glycol 400, propylene glycol, purified

water, shellac, sorbitol solution, titanium dioxide.

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL-
Valumeds Stool Softener 100capgels Bottle Labels

VALUMEDS

Compare to the active ingredient in

Colace ® Gel Caps *

STOOL

SOFTENER

DOCUSATE SODIUM 100 mg

  • Gentle
  • Effective
  • Stimulant-Free Relief

100 GELCAPS

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-0305
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 
PROPYLENE GLYCOL 
SHELLAC 
WATER 
GELATIN 
GLYCERIN 
SORBITOL 
D&C RED NO. 33 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite, redScoreno score
ShapeCAPSULESize12mm
FlavorImprint Code413
Contains    
Packaging
#Item CodePackage Description
1NDC:68210-0305-1100 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:68210-0305-31 BOTTLE in 1 CARTON
230 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/18/2017
Labeler - Spirit Pharmaceuticals LLC (179621011)
Establishment
NameAddressID/FEIOperations
MEDGEL PRIVATE LIMITED677385498manufacture(68210-0305)

 
Spirit Pharmaceuticals LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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