DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Proficient Rx LP

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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

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

Warnings

Do not use

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

Ask a doctor before use if you have

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

Stop use and ask a doctor if

you have rectal bleeding
you fail to have a bowel movement after use
you need to use a stool softener 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

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

adults and children 12 years and over                        

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other information

each capsule contains sodium 6 mg
store at room temperature 15o-30oC (59o-86oF)
Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients: D&C red #33, Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special

Questions?

Adverse drug event call (800) 687-0176

Principal Display Panel

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

63187-476-00
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-476(NDC:66424-030)
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 RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
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:63187-476-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
2NDC:63187-476-6060 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
3NDC:63187-476-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
4NDC:63187-476-00100 in 1 BOTTLE; Type 0: Not a Combination Product01/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00709/15/2010
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(63187-476) , RELABEL(63187-476)

Revised: 2/2024
Document Id: 5c0507c4-d04d-4453-b688-fa1d856f751d
Set id: f9ac0344-5864-4ac1-81bc-16878a5946c5
Version: 4
Effective Time: 20240201
 
Proficient Rx LP