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.

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Surfak Stool Softener

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

corn oil, gelatin, glycerin, hypromellose, isopropyl alcohol, mannitol, propylene glycol, red 33, red 40, sorbitol, titanium dioxide, water (283-042)

PRINCIPAL DISPLAY PANEL

Surfak®
Stool Softener
original formula
docusate calcium
100 SoftGels
240 mg docusate calcium per softgel

PRINCIPAL DISPLAY PANEL
Surfak Stool Softener

SURFAK STOOL SOFTENER
docusate calcium capsule, gelatin coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-6101
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE CALCIUM (UNII: 6K7YS503HC) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE CALCIUM	240 mg

Ingredient Name	Strength
Inactive Ingredients
CORN OIL (UNII: 8470G57WFM)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MANNITOL (UNII: 3OWL53L36A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	Surfak
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-6101-2	3 in 1 CARTON	01/01/2009	01/01/2017
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	01/01/2009	01/01/2017

Labeler - Chattem, Inc. (003336013)

Name	Address	ID/FEI	Business Operations
Establishment
Chattem Plant 1		003336013	ANALYSIS(41167-6101) , LABEL(41167-6101) , PACK(41167-6101)

Revised: 11/2017

Document Id: f6660705-84fb-4e1b-85fa-62c1e8a59153

Set id: a339a7ad-8469-42a9-963b-e428d3df53f7

Version: 6

Effective Time: 20171106

Chattem, Inc.