STOOL SOFTENER- docusate sodium capsule, liquid filled 
Bryant Ranch Prepack

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gc425 (426)

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool Softener

Uses

Warnings

Ask a doctor before use if you

Stop use and ask a doctor if

These 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

Other information

Inactive ingredients

FD&C red #40, FD&C yellow #6 (sunset yellow), gelatin, glycerol, PEG, purified water, sorbitol special

Questions or comments?

1-800-540-3765

HOW SUPPLIED

NDC: 71335-1677-1: 30 Capsules in a BOTTLE

NDC: 71335-1677-2: 60 Capsules in a BOTTLE

NDC: 71335-1677-3: 100 Capsules in a BOTTLE

NDC: 71335-1677-4: 7 Capsules in a BOTTLE

NDC: 71335-1677-5: 90 Capsules in a BOTTLE

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Docusate Sodium 250 mg Capsule

Label
STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71335-1677(NDC:57896-426)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM250 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeOVAL (oblong) Size20mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71335-1677-130 in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
2NDC:71335-1677-260 in 1 BOTTLE; Type 0: Not a Combination Product08/07/2020
3NDC:71335-1677-3100 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
4NDC:71335-1677-47 in 1 BOTTLE; Type 0: Not a Combination Product08/19/2022
5NDC:71335-1677-590 in 1 BOTTLE; Type 0: Not a Combination Product04/04/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00704/01/2020
Labeler - Bryant Ranch Prepack (171714327)
Registrant - Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(71335-1677) , RELABEL(71335-1677)

Revised: 4/2024
Document Id: 98bdddeb-53ee-4383-9a6f-d60d4082f450
Set id: 1f11cf85-b094-4ca4-8b48-2d3a9093304b
Version: 3
Effective Time: 20240404
 
Bryant Ranch Prepack