DOCUSATE SODIUM- docusate sodium capsule 
PD-Rx Pharmaceuticals, 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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Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

Warnings


Do not use

Do not use if you are currently taking mineral oil, unless directed bya doctor

Ask a doctor before use if you

  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that last 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 softner 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

adults and children over 12 years and older                        
take 1-3 softgels daily
children 2 to 12 years of age
take 1 softgel daily
children under 2 years
ask a doctor

Other information

Inactive ingredients: FD&C Red #33,Edible Ink,FD&C Red #40,FD&C Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Purified Water, Sorbitol Special.


Questions?

Adverse drug event call: (866) 562-2756

HOW SUPPLIED

Supplied in bottles of 14, 30, 60, 90 and 180 softgels.

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

100 mg each

image

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55289-493
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color red (Two-toned- white and clear red) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code SC02
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55289-493-14 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018
2 NDC:55289-493-30 30 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018
3 NDC:55289-493-60 60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018
4 NDC:55289-493-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018
5 NDC:55289-493-93 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 01/12/2018 01/31/2038
Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Business Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack(55289-493)

Revised: 9/2019
Document Id: 93cb9f2e-0247-09de-e053-2a95a90a05e2
Set id: 66ca7a94-378b-4476-8060-d9c6f82f57fc
Version: 7
Effective Time: 20190930
 
PD-Rx Pharmaceuticals, Inc.