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Docusate Sodium by Proficient Rx LP

Medically reviewed on Feb 1, 2018

Dosage form: capsule, liquid filled
Ingredients: Docusate Sodium 100mg
Labeler: Proficient Rx LP
NDC Code: 63187-476

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 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

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-476(NDC:66424-030)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (Docusate) Docusate Sodium100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
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:63187-476-3030 CAPSULE, LIQUID FILLED in 1 BOTTLE
2NDC:63187-476-6060 CAPSULE, LIQUID FILLED in 1 BOTTLE
3NDC:63187-476-9090 CAPSULE, LIQUID FILLED in 1 BOTTLE
4NDC:63187-476-00100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33409/15/2010
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574REPACK(63187-476), RELABEL(63187-476)

 
Proficient Rx LP

← See all Docusate Sodium brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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