FDA Label for Docusate Sodium
View Indications, Usage & Precautions
Docusate Sodium Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson Corporation Dba Sky Packaging. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 5 Ml)
Docusate sodium 50 mg
Purpose
Stool softener
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
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 stool softener laxative for more than 1 week
- rash occurs
Directions
- Dose once daily
- take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
adults and children 12 years and older | 5 to 20 mL (1 to 4 teaspoonfuls) |
children 6 to under 12 years of age | 5 to 10 mL (1 to 2 teaspoonfuls) |
children 3 to under 6 years of age | 2.5 to 5 mL (1/2 to 1 teaspoonful) |
children under 3 years | ask a doctor |
Other Information
- • Sodium content: 14 mg/ 5 mL
• Store at controlled room temperature, 20° to 25°C (68° to 77°F)
• Protect from freezing
• Protect from light
• Clear pink to purple-pink colored, cherry flavored liquid supplied in the following:
NDC 63739-976-01: 10 mL Unit Dose Cup
NDC 637369-976-10: case of 100, 10 mL Unit Dose Cups
Inactive Ingredients
artificial cherry vanilla flavoring, citric acid anhydrous, D&C Red No. 33, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate, and sorbitol.
Questions Or Comments?
Call 1-800-845-8210
Principal Display Panel - 5 Ml Cup Tray Label
Delivers 10 mL
NDC 63739-976-01
Docusate Sodium Liquid
100 mg/ 10 mL
STOOL SOFTENER LAXATIVE
Alcohol Free/Sugar Free
FOR INSTITUTIONAL USE ONLY
Dist. by: SKY Packaging
Memphis, TN 38141
SEE DRUG FACTS
F0935C101022
* Please review the disclaimer below.