DOCUSATE SODIUM - docusate sodium  capsule 
Bryant Ranch Prepack

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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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: 63629-1360

Docusate Sodium 100mg Capsule

Label Image
DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63629-1360(NDC:16103-384)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
FD&C Red No. 40 (UNII: WZB9127XOA)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitol (UNII: 506T60A25R)  
Product Characteristics
Colorred (Two-toned- white and clear red) Scoreno score
ShapeOVALSize5mm
FlavorImprint Code 51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-1360-710 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
2NDC:63629-1360-828 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
3NDC:63629-1360-130 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
4NDC:63629-1360-956 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
5NDC:63629-1360-360 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
6NDC:63629-1360-590 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
7NDC:63629-1360-2100 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
8NDC:63629-1360-4120 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
9NDC:63629-1360-6180 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
10NDC:63629-1360-050 in 1 BOTTLE; Type 0: Not a Combination Product01/22/200712/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/22/200712/31/2017
Labeler - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-1360) , RELABEL(63629-1360)

Revised: 11/2018
Document Id: 503c5b9a-7e19-477e-94c0-61fac1324f2c
Set id: bb03e4f1-16f8-da04-1262-2eeecb19568e
Version: 5
Effective Time: 20181126
 
Bryant Ranch Prepack