DOCQLACE - docusate sodium capsule 
Qualitest Pharmaceuticals

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DocQLace

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

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

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.

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

• each softgel contains: sodium 5 mg VERY LOW SODIUM
• store at 15°- 30°C (59°- 86°F)
• keep tightly closed

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

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: 12/2010Qualitest Pharmaceuticals