docusate sodium

Drug Facts

Composition & Product

Active Ingredients

docusate (50 mg)

Inactive Ingredients

anhydrous citric acid d&c red no. 33 glycerin methylparaben polyethylene glycol, unspecified propylene glycol propylparaben water saccharin sodium sodium citrate, unspecified form sorbitol solution

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

otc monograph drug active Since 2023-12-26

Medication Information

Uses

•
relieves occasional constipation (irregularity)
•
generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener

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, 20º to 25ºC (68º to 77ºF)
•
Protect from freezing
•
Protect from light
•
Clear pink to purple colored, cherry-vanilla flavored liquid supplied in the following

Overbagged with 5 x 10 mL unit dose cups per bag, NDC 55154-2346-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Description

(in each 5 mL) Docusate sodium 100 mg

Principal Display Panel

NDC 55154-2346-5

DOCUSATE SODIUM LIQUID

100 MG / 10 mL

5 CUPS

Do Not Use

•
if you are presently taking mineral oil, unless told to do so by a doctor

Distributed By:

R06/22

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L58458960724

Active Ingredient

(in each 5 mL)

Docusate sodium 100 mg

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

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

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.

Ask A Doctor Before Use If You Have

•
stomach pain
•
nausea
•
vomiting
•
noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses

•
relieves occasional constipation (irregularity)
•
generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener

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 (Other information)

•
Sodium content: 14 mg/5 mL
•
Store at controlled room temperature, 20º to 25ºC (68º to 77ºF)
•
Protect from freezing
•
Protect from light
•
Clear pink to purple colored, cherry-vanilla flavored liquid supplied in the following

Overbagged with 5 x 10 mL unit dose cups per bag, NDC 55154-2346-5

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Principal Display Panel

NDC 55154-2346-5

DOCUSATE SODIUM LIQUID

100 MG / 10 mL

5 CUPS

Do Not Use (Do not use)

•
if you are presently taking mineral oil, unless told to do so by a doctor

Distributed By: (Distributed by:)

R06/22

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L58458960724

Active Ingredient

(in each 5 mL)

Docusate sodium 100 mg

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? (Questions or comments?)

Call 1-800-845-8210

Stop Use and Ask A Doctor If (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

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.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
stomach pain
•
nausea
•
vomiting
•
noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data

[{"name": "DOCUSATE", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL SOLUTION", "unii": "8KW3E207O2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• relieves occasional constipation (irregularity) • generally produces bowel movement in 12 to 72 hours", "Purpose": "Stool softener", "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", "Do not use": "• if you are presently taking mineral oil, unless told to do so by a doctor", "Distributed by:": "R06/22 MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Distributed By: Cardinal Health Dublin, OH 43017 L58458960724", "Active Ingredient": "(in each 5 mL) Docusate sodium 100 mg", "Other information": "• Sodium content: 14 mg/5 mL • Store at controlled room temperature, 20º to 25ºC (68º to 77ºF) • Protect from freezing • Protect from light • Clear pink to purple colored, cherry-vanilla flavored liquid supplied in the following Overbagged with 5 x 10 mL unit dose cups per bag, NDC 55154-2346-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.", "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": "NDC 55154-2346-5 DOCUSATE SODIUM LIQUID 100 MG / 10 mL 5 CUPS", "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 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.", "Ask a doctor before use if you have": "• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that lasts over 2 weeks"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information