DOCUSATE CALCIUM- docusate calcium capsule 
NCS HealthCare of KY, Inc 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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Active ingredient(s)

Docusate Calcium

Purpose

Stool Softener

Use(s)

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

Warnings

Do not use

-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.

Ask a doctor or pharmacist 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

Pregnancy/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

-do not use if imprinted safety seal under cap is broken or missing

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

Storage

Store at controlled room temperature 15 degrees-30 degrees C (59 degrees-86 degrees F)

Inactive ingredients

Corn oil, D&C Red #33, 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

Rev. 10/09

M-58

Principal Display Panel

Docusate Calcium Softgel Capsules

240mg

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
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize21mm
FlavorImprint Code P58
Contains    
Packaging
#Item CodePackage Description
1NDC:0615-0378-3930 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33407/01/2010
Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, Inc dba Vangard Labs050052943RELABEL, REPACK

Revised: 07/2010
Document Id: 8ad84707-10b1-4dff-8c50-8477b91162e4
Set id: 96a3a9f4-a6c4-4055-a0c1-79c6267a42d0
Version: 1
Effective Time: 20100714
 
NCS HealthCare of KY, Inc dba Vangard Labs