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Docusate Calcium by Rebel Distributors Corp

Medically reviewed on Sep 7, 2018

Dosage form: capsule
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Rebel Distributors Corp
NDC Code: 21695-980

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(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: Rugby Laboratories, Inc. Duluth GA 30097

Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Principal Display Panel

Docusate Calcium Softgel Capsules

240mg

DOCUSATE CALCIUM 
docusate calcium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-980(NDC:0536-3755)
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:21695-980-0707 CAPSULE (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/01/2010
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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Further information

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

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