Docusate Sodium
SPL UNCLASSIFIED SECTION
Drug Facts
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
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 stool softener laxative for more than 1 week
- rash occurs
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 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 |
- Dose once daily
- take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
Other information
NDC 0121-0935-16: 16 fl oz (473 mL) bottle NDC 0121-0935-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1870-10: 10 mL unit dose cup, in a tray of ten cups.
- • 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:
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.
SPL UNCLASSIFIED SECTION
MANUFACTURED BY
Pharmaceutical Associates, Inc.
Greenville, SC 29605
R12/20