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Docusate Sodium by Bryant Ranch Prepack

Medically reviewed on October 12, 2017

Dosage form: capsule
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Bryant Ranch Prepack
NDC Code: 63629-1360

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.

DOCUSATE SODIUM

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 ifThese could be signs of a serious condition
  • you have no bowel movement after 3 days
  • you have rectal bleeding

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

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

Docusate Sodium 100mg Capsule
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-1360(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 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SORBITOL 
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code51A
Contains    
Packaging
#Item CodePackage Description
1NDC:63629-1360-130 CAPSULE in 1 BOTTLE
2NDC:63629-1360-2100 CAPSULE in 1 BOTTLE
3NDC:63629-1360-360 CAPSULE in 1 BOTTLE
4NDC:63629-1360-4120 CAPSULE in 1 BOTTLE
5NDC:63629-1360-590 CAPSULE in 1 BOTTLE
6NDC:63629-1360-6180 CAPSULE in 1 BOTTLE
7NDC:63629-1360-710 CAPSULE in 1 BOTTLE
8NDC:63629-1360-828 CAPSULE in 1 BOTTLE
9NDC:63629-1360-956 CAPSULE in 1 BOTTLE
10NDC:63629-1360-050 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/22/2007
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIOperations
Accucaps Industries Ltd.248441727MANUFACTURE(63629-1360)
Establishment
NameAddressID/FEIOperations
Bryant Ranch Prepack171714327REPACK(63629-1360), RELABEL(63629-1360)

 
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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