Docusate Sodium

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL)
Docusate sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

SPL UNCLASSIFIED SECTION

• 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:

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-800-845-8210

Distributed by:

SPL UNCLASSIFIED SECTION

R06/22

MAJOR® PHARMACEUTICALS
Indianapolis, IN  46268

Distributed By:

Cardinal Health

Dublin, OH 43017

L58458960724

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-2346-5

DOCUSATE SODIUM LIQUID

100 MG / 10 mL

5 CUPS

DailyMed RxNorm Mappings#

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DailyMed Package Descriptions#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

• Docusate Sodium
• DOCUSATE
• 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

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.