Docusate Sodium Liquid

Docusate Sodium Liquid
SPL v1
SPL
SPL Set ID e5028f6d-d33d-47a9-8453-00af5cdf59a6
Route
ORAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Anhydrous Citric Acid D&c Red No. 33 Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Saccharin Sodium Sorbitol Solution

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-20

Description

Docusate sodium 100 mg

Purpose

Stool softener


Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Do Not Use
  • if you are presently taking mineral oil, unless told to do so by a doctor
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

Distributed By:

American Health Packaging

Columbus, OH 43217

R12/24

Active Ingredient

Docusate sodium 100 mg

Other Information
  • Sodium content: 28 mg / 10 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-vanilla flavored liquid supplied in the following:

10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56

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

DO NOT USE IF SEAL IS BROKEN.

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
Principal Display Panel – Tray Label

Case NDC 60687-878-56/Cup NDC 60687-878-42

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

For Institutional Use Only

T0935C101224            R12/24

Principal Display Panel – Cup – 100 Mg / 10 Ml

NDC 60687- 878-42

Docusate Sodium

Liquid

Stool Softener Laxative

100 mg/10 mL

Alcohol Free/Sugar Free

Delivers 10 mL

Protect from freezing. Protect from light.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0935C100125


Structured Label Content

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

Stool softener

Do Not Use (Do not use)
  • if you are presently taking mineral oil, unless told to do so by a doctor
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

Distributed By: (Distributed by:)

American Health Packaging

Columbus, OH 43217

R12/24

Active Ingredient (Active ingredient)

Docusate sodium 100 mg

Other Information (Other information)
  • Sodium content: 28 mg / 10 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-vanilla flavored liquid supplied in the following:

10 mL unit dose cups: 100 cups (10 x 10) NDC 60687-878-56

Inactive Ingredients: (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

DO NOT USE IF SEAL IS BROKEN.

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, (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
Principal Display Panel – Tray Label

Case NDC 60687-878-56/Cup NDC 60687-878-42

Docusate Sodium Liquid

100 mg/10 mL

STOOL SOFTENER LAXATIVE

Alcohol Free/Sugar Free

USUAL DOSAGE: See attached Drug Facts

Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].

For Institutional Use Only

T0935C101224            R12/24

Principal Display Panel – Cup – 100 Mg / 10 Ml (Principal Display Panel – Cup – 100 mg / 10 mL)

NDC 60687- 878-42

Docusate Sodium

Liquid

Stool Softener Laxative

100 mg/10 mL

Alcohol Free/Sugar Free

Delivers 10 mL

Protect from freezing. Protect from light.

See package Drug Facts insert for full

prescribing information and storage.

For Institutional Use Only.

American Health Packaging

Columbus, OH 43217

F0935C100125


Advanced Ingredient Data


Raw Label Data

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