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DOK by Bryant Ranch Prepack

Medically reviewed on December 27, 2017

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 250mg
Labeler: Bryant Ranch Prepack
NDC Code: 71335-0550

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 250 mg

Purpose

Stool softener laxative

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

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor.

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if
  • 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

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
  • adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information
  • each softgel contains: sodium 15 mg
  • store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients​

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitol special

*may contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

HOW SUPPLIED

Product: 71335-0550

NDC: 71335-0550-4 7 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0550-1 30 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0550-2 60 CAPSULE, LIQUID FILLED in a BOTTLE

NDC: 71335-0550-3 100 CAPSULE, LIQUID FILLED in a BOTTLE

Docusate Sodium 250mg Capsule
DOK 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-0550(NDC:0904-6458)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN, UNSPECIFIED 
GLYCERIN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SORBITAN 
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeSCU1
Contains    
Packaging
#Item CodePackage Description
1NDC:71335-0550-47 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:71335-0550-130 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:71335-0550-260 CAPSULE, LIQUID FILLED in 1 BOTTLE
4NDC:71335-0550-3100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/28/2015
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(71335-0550), RELABEL(71335-0550)

 
Bryant Ranch Prepack

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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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