DOCUSATE SODIUM 100MG TWO-TONE- docusate sodium capsule, liquid filled 
Discount Drug Mart, 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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DOCUSATE SODIUM 100mg Two-Tone, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

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 movements that lasts over 2 weeks

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 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

Take only by mouth. 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

Inactive Ingredients

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerol, Polyethylene glycol, purified water, sorbitol, titanium dioxide

Image of carton

DOCUSATE SODIUM 100MG TWO-TONE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-250
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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 (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred, white (Two-Tone) Scoreno score
ShapeCAPSULE (OVAL) Size10mm
FlavorImprint Code SCU2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53943-250-251 in 1 CARTON12/23/2019
1250 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:53943-250-101 in 1 CARTON12/23/2019
2100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/23/2019
Labeler - Discount Drug Mart, Inc (047741335)
Registrant - Reese Pharmaceutical (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Swiss Caps Romania565466997manufacture(53943-250)

Revised: 12/2022
Document Id: 2690d9b1-b70a-4185-8447-14f9acac9646
Set id: 80092188-0517-4646-bd46-ab56c63bb354
Version: 3
Effective Time: 20221228
 
Discount Drug Mart, Inc