OTC Medication Information: Surfak Stool Softener

SURFAK STOOL SOFTENER- docusate calcium capsule, gelatin coated
Chattem, Inc.

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.

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

Description: PRINCIPAL DISPLAY PANEL
Surfak Stool Softener 
original formula
(click image for full-size original)
SURFAK STOOL SOFTENER
docusate calcium capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-6100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE CALCIUM (DOCUSATE) DOCUSATE CALCIUM 240 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
CORN OIL
GELATIN
GLYCERIN
Polyvinyl Acetate Phthalate
PROPYLENE GLYCOL
FD&C RED NO. 40
SORBITOL
TITANIUM DIOXIDE
Product Characteristics
Color RED Score no score
Shape OVAL Size 20mm
Flavor Imprint Code Surfak
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-6100-6 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-6100-6)
2 NDC:41167-6100-2 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (41167-6100-2)
3 NDC:41167-6100-3 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 01/01/2009
Labeler — Chattem, Inc. (003336013)

Revised: 01/2018 Chattem, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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