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Surfak Stool Softener

Dosage form: capsule, gelatin coated
Ingredients: DOCUSATE CALCIUM 240mg
Labeler: Chattem, Inc.
NDC Code: 41167-6100

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.

Surfak Stool Softener Original Formula

Drug Facts

Active ingredient

(in each softgel)

Docusate calcium 240 mg

Purpose

Stool softener laxative

Uses
  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours

Warnings

Do not use
  • when stomach pain, nausea or vomiting are present unless directed by a doctor

Ask a doctor before use if you have
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use

if you are presently taking mineral oil

Stop use and ask a doctor if
  • you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding, ask a health 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 12 years of age or over: one softgel daily
  • children under 12 years of age: ask a doctor

Other information
  • protect from heat, humidity and light

Inactive ingredients

blue 1, corn oil, gelatin, glycerin, polyvinyl acetate phthalate, propylene glycol, red 40, sorbitol, titanium dioxide (245-198)

PRINCIPAL DISPLAY PANEL

Formerly Kaopectate® Stool Softener
Surfak® Stool Softener original formula
10 SoftGels 240 mg docusate calcium per softgel

SURFAK STOOL SOFTENER 
docusate calcium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-6100
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM240 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
CORN OIL 
GELATIN 
GLYCERIN 
Polyvinyl Acetate Phthalate 
PROPYLENE GLYCOL 
FD&C RED NO. 40 
SORBITOL 
TITANIUM DIOXIDE 
Product Characteristics
ColorREDScoreno score
ShapeOVALSize20mm
FlavorImprint CodeSurfak
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-6100-61 BLISTER PACK in 1 CARTON
110 CAPSULE, GELATIN COATED in 1 BLISTER PACK
2NDC:41167-6100-23 BLISTER PACK in 1 CARTON
210 CAPSULE, GELATIN COATED in 1 BLISTER PACK
3NDC:41167-6100-3100 CAPSULE, GELATIN COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/01/2009
Labeler - Chattem, Inc. (003336013)

Revised: 01/2018
 
Chattem, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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