DOCQLACE - docusate sodium capsule 
Qualitest Pharmaceuticals

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DocQLace

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

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

Stop use and ask a doctor if

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

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

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol 400, purified water, sorbitol special

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

Rev. 7/10 R3
8082517  0145

PRINCIPAL DISPLAY PANEL

This is an image of a DocQLace label.
This is an image of a DocQLace label.

DOCQLACE 
docusate sodium   capsule
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 0603-0145
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40  
FD&C YELLOW NO. 6  
GELATIN  
GLYCERIN  
POLYETHYLENE GLYCOL 400  
WATER  
SORBITOL  
Product Characteristics
Color RED (reddish) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code 0145
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 0603-0145-21 100 CAPSULE In 1 BOTTLE, PLASTIC None
2 0603-0145-32 1000 CAPSULE In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 02/01/1996

Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Swiss Caps USA, INC 033105888 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Charlotte 151228897 LABEL, PACK
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 825839835 LABEL, PACK
Revised: 12/2010 Qualitest Pharmaceuticals