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Docusate Sodium

Dosage form
LIQUID
Labeler
PAI Holdings, LLC dba PAI Pharma
Label updated
2025-02-06
Retrieved
2026-09-07
Active ingredients
DOCUSATE SODIUM
View original label and images on DailyMed ↗
Label information

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

Label information

If pregnant or breast-feeding, ask a health professional before use.

Label information

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 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.


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

Label information

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

R12/20

PRINCIPAL DISPLAY PANEL - 16 fl oz (473 ML)

NDC 0121-0935-16

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

16 fl oz (473 mL)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

X0935160721 R07/21

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL - 5 mL Cup LIdding

NDC 0121-0935-05

Docusate Sodium Liquid

50 mg/5 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

[Image in the official label — see DailyMed source]

PRINCIPAL DISPLAY PANEL - 10 mL Cup Lidding

NDC 0121-1870-10

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

Greenville, SC 29605

[Image in the official label — see DailyMed source]

DailyMed Set ID: e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5 · Version 9
NDC: 0121-0935, 0121-1870