DOC Q LACE  - docusate sodium liquid 
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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Active Ingredient: Docusate sodium 10 mg (in each mL)

Purpose: Stool Softener

Uses

Warnings

Do not use
Ask a doctor before use if you have
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.

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 over 12 years of age and older
50 to 200 mg (1 to 4 teaspoonful)
Children 6 to under 12 years of age
50 to 100 mg (1 to 2 teaspoonful)
Children 3 to under 6 years of age
25 to 50 mg(1/2 to 1 teaspoonful)
children under 3 years of age
Ask a doctor
Other information

Inactive ingredients

citric acid, D&C red no. 33, flavor, methylparaben, Poloxamer, propylene glycol, propylparaben, purified water, sodium citrate.

You may report serious side effects to:

130 Vintage Drive
Huntsville, AL 35811
USA

Container Label


DOC Q LACE 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0746
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (Docusate) Docusate sodium10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
methylparaben 
propylene glycol 
propylparaben 
sodium citrate 
water 
Poloxamer 407 
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON (Lemon Vanilla Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:0603-0746-58473 mL in 1 BOTTLE, PLASTICNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/05/1990

Labeler - Qualitest Pharmaceuticals (011103059)
Registrant - Silarx Pharmaceuticals, Inc (161630033)

Revised: 11/2011 Qualitest Pharmaceuticals