Docusate Sodium Oral Liquid

Docusate Sodium Oral Liquid
SPL v1
SPL
SPL Set ID 331277b8-8304-d082-e063-6394a90a4dd3
Route
ORAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Propylene Glycol Sucralose Potassium Citrate Sorbitol Grape Propylparaben Water Citric Acid Monohydrate Ammonium Glycyrrhizate Methylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01
Description

Docusate Sodium 100 mg

Purpose

Stool Softener Laxative

Medication Information

Purpose

Stool Softener Laxative

Description

Docusate Sodium 100 mg

Uses
  • relieves of occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 34088-5

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

Section 42229-5

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Rev. 04/2025

Section 51945-4

NDC 81033-022-50

Docusate Sodium Oral Liquid 100 mg/10 mL

Delivers 10 mL Case = 100 UD Cups (Do Not Break Case)

Storage: 68ºF to 77ºF (20ºC to 25ºC)

QTY: 1

Directions
  • shake well before using
  • must be given in a 6 oz to 8 oz glass of milk, fruit juice or infant formula to mask the bitter taste and prevent throat irritation
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • follow dosing directions below or use as directed by a doctor
1 teaspoonful = 5 mL
Age Dose
adults and children 12 years and older 1 to 7 teaspoonfuls
children 2 to under 12 years of age 1 to 3 teaspoonfuls
children under 2 years of age ask a doctor

Do Not Use
  • for more than 1 week unless directed by a doctor
  • if you are currently taking mineral oil, unless directed by a doctor
Other Information
  • store at controlled room temperature 20°C to 25°C (68°F to 77°F)
  • protect from light
  • protect from excessive heat
  • protect from freezing
  • clear, grape-flavored liquid, supplied in the following:

NDC 81033-022-10: 10 mL unit dose cup

NDC 81033-022-50 : Case containing 100 unit dose cups of 10 mL each

Inactive Ingredients

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions Or Comments?

Call 1-833-537-4679

Stop Use and Ask A Doctor If
  • you have rectal bleeding or failure to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation
If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each 5ml)

Docusate Sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

Structured Label Content

Uses
  • relieves of occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

Packaged by:

Kesin Pharma

Oldsmar, FL 34677

Rev. 04/2025

Section 51945-4 (51945-4)

NDC 81033-022-50

Docusate Sodium Oral Liquid 100 mg/10 mL

Delivers 10 mL Case = 100 UD Cups (Do Not Break Case)

Storage: 68ºF to 77ºF (20ºC to 25ºC)

QTY: 1

Purpose

Stool Softener Laxative

Directions
  • shake well before using
  • must be given in a 6 oz to 8 oz glass of milk, fruit juice or infant formula to mask the bitter taste and prevent throat irritation
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • follow dosing directions below or use as directed by a doctor
1 teaspoonful = 5 mL
Age Dose
adults and children 12 years and older 1 to 7 teaspoonfuls
children 2 to under 12 years of age 1 to 3 teaspoonfuls
children under 2 years of age ask a doctor

Do Not Use (Do not use)
  • for more than 1 week unless directed by a doctor
  • if you are currently taking mineral oil, unless directed by a doctor
Other Information
  • store at controlled room temperature 20°C to 25°C (68°F to 77°F)
  • protect from light
  • protect from excessive heat
  • protect from freezing
  • clear, grape-flavored liquid, supplied in the following:

NDC 81033-022-10: 10 mL unit dose cup

NDC 81033-022-50 : Case containing 100 unit dose cups of 10 mL each

Inactive Ingredients (Inactive ingredients)

citric acid, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

Call 1-833-537-4679

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or failure to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • a skin rash occurs
  • you experience throat irritation
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each 5ml) (Active ingredient (in each 5mL))

Docusate Sodium 100 mg

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 persists over a period of 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:59.840709 · Updated: 2026-03-14T23:08:27.251685