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Docusate Sodium by A-S Medication Solutions

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: A-S Medication Solutions
NDC Code: 50090-0357

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.

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses
  • prevents/relieves dry hard stool
  • results usually occurs 1 to 3 days after the first dose

Warnings

Do not use
  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor

Ask a doctor before use if you
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

you have no bowel movement after 3 daysyou have rectal bleedingThese could be signs of a serious condition

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.

Directions
  • do not exceed recommended dose
adults and children over 12 years                        
take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years
take 1 softgel daily
children under 6 years
consult a doctor

Other information
  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • store at room temperature 15o to 30oC (59o to 86oF)
  • protect from moisture

Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.

Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Product: 50090-0357

NDC: 50090-0357-0 20 CAPSULE in a BOTTLE

NDC: 50090-0357-2 60 CAPSULE in a BOTTLE

NDC: 50090-0357-4 30 CAPSULE in a BOTTLE

NDC: 50090-0357-1 100 CAPSULE in a BOTTLE

Docusate Sodium
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-0357(NDC:16103-384)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C Yellow No. 10 
FD&C Red No. 40 
GELATIN, UNSPECIFIED 
Glycerin 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Propylene Glycol 
Sorbitol 
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code51A
Contains    
Packaging
#Item CodePackage Description
1NDC:50090-0357-0 20 CAPSULE in 1 BOTTLE
2NDC:50090-0357-2 60 CAPSULE in 1 BOTTLE
3NDC:50090-0357-4 30 CAPSULE in 1 BOTTLE
4NDC:50090-0357-1 100 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/22/2007
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIOperations
A-S Medication Solutions830016429RELABEL(50090-0357), REPACK(50090-0357)

Revised: 09/2017
 
A-S Medication Solutions

← See all Docusate Sodium brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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