TOPCARE STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled 
TOPCO ASSOCIATES LLC

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 250 mg Two-Tone, Capsule, liquid filled

Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250 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

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DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007
©TOPCO RSEA0621 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com

TOPCARE STOOL SOFTENER  LAXATIVE
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-764
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
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)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorred, white (Two-Tone) Scoreno score
ShapeCAPSULE (OVAL) Size20mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-764-10100 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/20/2021
Labeler - TOPCO ASSOCIATES LLC (006935977)
Registrant - Reese Pharmaceutical (004172052)

Revised: 12/2022
Document Id: 34a11108-7d23-406c-a1f2-eb49cfed8de7
Set id: f9302fc2-684d-4cc2-bdd7-7ad0e9304edb
Version: 3
Effective Time: 20221229
 
TOPCO ASSOCIATES LLC