DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
Redpharm Drug, Inc.

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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Perrigo Docusate Sodium 100 mg Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

Warnings

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

do not exceed the maximum recommended daily dosage in a 24-hour period

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a 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. (1-800-222-1222)

Directions

adults and children 12 years and over

take 1 - 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years

ask a doctor

Other information

Inactive ingredients

D&C red no. 33, edible ink, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

1-800-719-9260

Principal Display Panel

Compare to Colace ® active ingredient

Docusate Sodium

100 mg

Stool Softener Laxative

Gentle and Predictable

Relief of Constipation

100 Softgels

Stimulant Free

Docusate Sodium Image 1
Docusate Sodium Image 2
Docusate Sodium Image 3
DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67296-1835(NDC:45802-486)
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 BLUE NO. 1 (UNII: H3R47K3TBD)  
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)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colorred, white (to off beige) Scoreno score
ShapeOVAL (softgel) Size13mm
FlavorImprint Code L486
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67296-1835-220 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2008
2NDC:67296-1835-660 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/28/2008
Labeler - Redpharm Drug, Inc. (828374897)
Establishment
NameAddressID/FEIBusiness Operations
Redpharm Drug, Inc.828374897repack(67296-1835)

Revised: 2/2023
Document Id: f4236180-d2bd-3a1e-e053-2a95a90a84b9
Set id: f4236180-d2bc-3a1e-e053-2a95a90a84b9
Version: 1
Effective Time: 20230207
 
Redpharm Drug, Inc.