DOCUSATE CALCIUM- docusate calcium capsule 
NCS HealthCare of KY, LLC dba Vangard Labs

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 Calcium

Active ingredient (in each softgel)

Docusate Calcium 240mg

Purpose

Stool Softener

Uses

For relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

-if you are currently taking mineral oil, unless directed by a doctor

-when abdominal pain, nausea, or vomiting are present

-for longer than 1 week, unless directed by a doctor

Ask a doctor before use if

- you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

-you have rectal bleeding

-you fail to have a bowel movement after use

If pregnant or breastfeeding

ask a health care 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 of age: take 1 softgel daily for several days, or until bowel movements are normal, or as directed by a doctor

-children under 12 years of age: take as directed by a doctor

Other information

-store at controlled room temperature 15º - 30ºC (59º - 86ºF)

-*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Surfak® Stool Softener.

Inactive ingredients

Corn oil, D&C Red #33, edible white ink, FD&C Red #40, gelatin, glycerin, purified water and sorbitol special.

Questions?

Adverse Drug Event Call: (800) 616-2471

Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150, USA

Principal Display Panel

Docusate Calcium Softgel Capsules

240mg

Principal Display Panel- Docusate Calcium Softgel Capsules 240mg
DOCUSATE CALCIUM 
docusate calcium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0378(NDC:0904-5779)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorredScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code P58
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0615-0378-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product12/01/201108/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/01/201108/31/2016
Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-0378)

Revised: 4/2021
 
NCS HealthCare of KY, LLC dba Vangard Labs