STOOL SOFTENER- docusate sodium capsule, liquid filled
International Laboratories, LLC

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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International Laboratories, Inc. Docusate Sodium 100 mg Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

• if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

do not exceed the maximum recommended daily dosage in a 24-hour period

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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. (1-800-222-1222)

Directions

• Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

adults and children 12 years and over	take 1-3 softgels daily
children 2 to under 12 years of age	take 1 softgel daily
children under 2 years	ask a doctor

Other information

• each softgel contains: sodium 6 mg
• very low sodium
• store at 20-25ºC (68-77ºF)

Inactive ingredients

D&C red no. 33, edible ink, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-800-579-1868

PRINCIPAL DISPLAY PANEL

Drug Facts Label

Docusate Sodium LB0381

PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Colace® Capsules

Stool Softener

DOCUSATE SODIUM, 100 mg

Stool softener laxative

Relieves constipation

Gentle stool softener
Reliable relief

14 SOFTGELS

Actual Size

LIFT HERE TO OPEN

Stool Softener

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54458-853
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED, WHITE (to off beige)	Score	no score
Shape	OVAL (softgel)	Size	13mm
Flavor		Imprint Code	L486
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54458-853-14	14 in 1 BLISTER PACK; Type 0: Not a Combination Product	06/01/2016	06/09/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	06/01/2016	06/09/2017

Labeler - International Laboratories, LLC (023569924)

Name	Address	ID/FEI	Business Operations
Establishment
L. Perrigo Company		006013346	MANUFACTURE(54458-853) , RELABEL(54458-853) , REPACK(54458-853)

Revised: 12/2017

Document Id: 7001677a-14b6-4d51-a91a-b0021472d082

Set id: 3d2211af-9742-49e8-9016-51902e52bde4

Version: 5

Effective Time: 20171205

International Laboratories, LLC