Docusate Calcium by AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 DRUG FACTS

Docusate Calcium by

Drug Labeling and Warnings

Docusate Calcium by is a Otc medication manufactured, distributed, or labeled by AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOCUSATE CALCIUM STOOL SOFTENER- docusate calcium capsule, liquid filled 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385

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 Calcium 240 mg

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 - 30o C (59o- 86o F)
  • 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.

Inactive Ingredients

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

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Compare to Surfak® Active Ingredient*

DOCUSATE CALCIUM 240 mg

Stool softener

gentle relief of constipation

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

good neighbour pharmacy stool softener softgels

Docusate Calcium 240 mg

 

DOCUSATE CALCIUM  STOOL SOFTENER
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 24385-435
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: 24385-435-781 in 1 CARTON07/12/201012/30/2019
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/12/201012/30/2019
Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385 (007914906)

Revised: 10/2016
Document Id: cc99f774-f1e4-4424-abef-809c4564d49f
Set id: edb7b149-82a3-47c6-aaed-5d65ac12dd5f
Version: 2
Effective Time: 20161025
 
AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) 24385