Label: DOCQLACE - docusate sodium syrup
- NDC Code(s): 0603-0747-58
- Packager: Qualitest Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
Active Ingredient (in each 15 mL (1 tablespoonful)) :Docusate sodium 60 mgClose
Purpose: Stool SoftenerClose
- for gentle, reliable relief from occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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
- stomach pain
- noticed a sudden change in bowel habits that last over two weeks
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- Store at room temperature 20° -25°C.
- Protect from freezing and excessive heat
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.Close
Huntsville, AL 35811 USA
- INGREDIENTS AND APPEARANCE
docusate sodium syrup
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0747 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 20 mg in 5 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) D&C red no. 33 (UNII: 9DBA0SBB0L) methylparaben (UNII: A2I8C7HI9T) propylene glycol (UNII: 6DC9Q167V3) propylparaben (UNII: Z8IX2SC1OH) sodium citrate (UNII: 1Q73Q2JULR) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sucrose (UNII: C151H8M554) FD&C red no. 40 (UNII: WZB9127XOA) alcohol (UNII: 3K9958V90M) glycerin (UNII: PDC6A3C0OX) Product Characteristics Color Score Shape Size Flavor PEPPERMINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0603-0747-58 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 10/05/1990 Labeler - Qualitest Pharmaceuticals (011103059)