DOCQLACE- docusate sodium capsule 
Qualitest Pharmaceuticals

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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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, sorbital special

Manufactured for:
QUALITEST PHARMACEUTICALS
HUNTSVILLE, AL 35811

R0  07/2011
015021CPR

PRINCIPAL DISPLAY PANEL

This is an image of the label for DocQLace 100 count softgels. 

DOCQLACE 
docusate sodium capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color RED (Reddish) Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code SCU1
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-0150-21 100 in 1 BOTTLE, PLASTIC
2 NDC:0603-0150-32 1000 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 08/01/2011
Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 10/2012
Document Id: 97fd49a9-3242-4dc7-b676-bf4b9f547dad
Set id: 1605ce36-e636-43e1-ac9d-e91454bc9c44
Version: 1
Effective Time: 20121008
 
Qualitest Pharmaceuticals