DOCUSATE CALCIUM- docusate calcium capsule, liquid filled 
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient

Active Ingredient (in each softgel)

Docusate Calcium 240 mg

Purpose

Stool Softener Laxative

Keep Out of Reach of Children

Keep out of Reach of Children.

Uses

■ prevents / relieves constipation

■prevents / relieves dry hard stool

■results usually occur 1 to 3 days after the first dose.

Warnings

Do not use

■for more than one week unless directed by a doctor.

Ask a doctor before use if you

■have abdominal pain, nausea, or vomiting

■have noticed a sudden change in bowel habits that lasts over 2 weeks.

Ask a doctor or pharmacist before use if you are taking mineral oil.

Stop use and ask a doctor if

■you have no bowel movement within 3 days

■you have rectal bleeding

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

This package is intended for institutional use only.

This package is not child resistant.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

■Adults and children 12 years of age and older:

take 1 softgel daily, or as recommended by your physician

■children under 12: ask a doctor

■do not exceed recommended dose.

Inactive ingredients

Corn oil, FD&C Red #40, Gelatin, Glycerin, Methylparaben, Propylparaben, Sorbitol. May also contain: D&C Red #33, Edible Ink, FD&C Blue #1, Mannitol, Water.

Other

■Store at room temperature, 15°C-30°C (59°F-86°F)

■Product from USA or Canada

■See window for lot number and expiration date

Compare to Active Ingredient in SURFAK®

*This product is not manufactured or distributed by the owner of the registered trademark SURFAK®.

Repackaged by:

Cardinal Health

Zanesville, OH 43701

Package/Label Principal Display Panel

Docusate Calcium Softgel

240 mg

Docusate Calcium pouch label

Package/Label Principal Display Panel

Docusate Calcium
240 Mg

100 Softgels

Carton

Package/Label Principal Display Panel Bag Label

Docusate Calcium

240 mg each

10 softgels

Bag

Package/Label Principal Display Panel Carton Label

Carton for assist
DOCUSATE CALCIUM 
docusate calcium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-1875(NDC:57896-424)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE CALCIUM) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
CORN OIL 
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
METHYLPARABEN 
PROPYLPARABEN 
SORBITOL 
D&C RED NO. 33 
FD&C BLUE NO. 1 
MANNITOL 
WATER 
Product Characteristics
ColorREDScoreno score
ShapeCAPSULESize20mm
FlavorImprint Code SCU
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-1875-4100 in 1 CARTON
1NDC:55154-1875-61 in 1 POUCH
2NDC:55154-1875-010 in 1 BAG
21 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/01/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK

Revised: 07/2011
 
Cardinal Health