Your browser does not support JavaScript! DOCQLACE (DOCUSATE SODIUM) SYRUP [QUALITEST PHARMACEUTICALS]
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DOCQLACE (docusate sodium) syrup
[Qualitest Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient (in each 15 mL (1 tablespoonful)) :Docusate sodium 60 mg

Purpose: Stool Softener

Uses

  • for gentle, reliable relief from occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use
  • laxative products for longer than 1 week unless told to do so by a doctor
  • 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 last over two 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.

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

  • take as directed by a doctor
  • doses must be given in a 6 to 8 oz glass of milk or fruit juice, to prevent throat irritation
  • take only by mouth. Dose may be taken as a single daily dose or in divided doses.
  • dosage should be adjusted to individual response
adults and children 12 years of age and older
1 to 6 tablespoonfuls, or as directed by a doctor
children 6 to under 12 years of age
1 to 2 1/2 tablespoonfuls, or as directed by a doctor
children under 6 years
Ask a doctor
Other information

  • Store at room temperature 20° -25°C.
  • Protect from freezing and excessive heat
You may report serious side effects to:
130 Vintage Drive, Huntsville, AL 35811

Inactive ingredients

alcohol (not more than 1%), citric acid, D&C red no. 33, FD&C red no.40, peppermint flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium benzoate, sodium citrate, sucrose.

Manufactured for:

Qualitest Pharmaceuticals
Huntsville, AL 35811 USA

Container Label

DOCQLACE 
docusate sodium syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0747
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate sodium (Docusate) Docusate sodium20 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
D&C red no. 33 
methylparaben 
propylene glycol 
propylparaben 
sodium citrate 
water 
sodium benzoate 
sucrose 
FD&C red no. 40 
alcohol 
glycerin 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0747-58473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/05/1990
Labeler - Qualitest Pharmaceuticals (011103059)

Revised: 12/2012
Document Id: 95206544-6a53-4ac2-b2e4-b33fb7782752
Set id: 3bbec27b-13a0-4bb6-bc1a-b89679cc9869
Version: 9
Effective Time: 20121228
 
Qualitest Pharmaceuticals

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