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Docusate Calcium by NCS HealthCare of KY, Inc dba Vangard Labs

Dosage form: capsule
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
NDC Code: 0615-0378

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.

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

DOCUSATE CALCIUM 
docusate calcium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-0378(NDC:0904-5779)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
D&C RED NO. 33 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
WATER 
SORBITOL 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize21mm
FlavorImprint CodeP58
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0378-3930 CAPSULE (30 CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/2011
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIOperations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL(0615-0378), REPACK(0615-0378)

 
NCS HealthCare of KY, Inc dba Vangard Labs

← See all Docusate Calcium brands

Medically reviewed on Feb 28, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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