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← See all Docusate Sodium brands

Docusate Sodium by Direct Rx

Medically reviewed on November 6, 2017

Dosage form: tablet
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Direct Rx
NDC Code: 61919-888

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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OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 100 mg

OTC - PURPOSE SECTION

Stool softener

INDICATIONS & USAGE SECTION


relieves occasional constipation (irregularity)  
generally produces bowel movement in 12 to 72 hours

OTC - DO NOT USE SECTION

Do not use if you are presently taking mineral oil, unless told to do so by a doctor

OTC - ASK DOCTOR SECTION


stomach pain  
nausea  
vomiting  
noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - STOP USE SECTION


you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.  
you need to use a laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

doses may be taken as a single daily dose or in divided doses

OTHER SAFETY INFORMATION

each softgel contains: sodium 5 mg VERY LOW SODIUM  
store at 15°-30°C (59°-86°F)  
keep tightly closed

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbital special

SPL UNCLASSIFIED SECTION

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0 07/2011
015021CPR

WARNINGS SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DOCUSATE SODIUM 
docusate sodium tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-888(NDC:0603-0150)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOL 400 
WATER 
SORBITOL 
Product Characteristics
Colorred (Reddish) Scoreno score
ShapecapsuleSize12mm
FlavorImprint CodeSCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:61919-888-71100 TABLET in 1 BOTTLE
2NDC:61919-888-3030 TABLET in 1 BOTTLE
3NDC:61919-888-6060 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/01/2015
Labeler - Direct Rx (079254320)
Establishment
NameAddressID/FEIOperations
Direct Rx079254320relabel(61919-888), repack(61919-888)

 
Direct Rx

← 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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