Docusate Sodium

Docusate Sodium
SPL v3
SPL
SPL Set ID ee14dfe2-405f-493a-a774-ce1b01d05dd4
Route
ORAL
Published
Effective Date 2025-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

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
Description

(in each 5 mL) Docusate sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

(in each 5 mL) Docusate sodium 100 mg

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

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
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

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.

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

Principal Display Panel

NDC 55154-2346-5

DOCUSATE SODIUM LIQUID

100 MG / 10 mL

5 CUPS

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

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:12.422872 · Updated: 2026-03-14T23:10:26.709421