FDA.reportPublic FDA data

Docusate Sodium Oral Liquid

Manufacturer
Kesin Pharma Corporation
Effective date
2025-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:46

Label at a glance#

ProductDocusate Sodium Oral Liquid
Active ingredientDOCUSATE SODIUM
Label structure12 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient (in each 5mL)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for more than 1 week unless directed by a doctor
  • if you are currently taking mineral oil, unless directed 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 persists over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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
AgeDose
adults and children 12 years and older1 to 7 teaspoonfuls
children 2 to under 12 years of age1 to 3 teaspoonfuls
children under 2 years of ageask a doctor

Other Information

OTHER SAFETY 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-833-537-4679

SPL UNCLASSIFIED SECTION

Packaged by:
Kesin Pharma
Oldsmar, FL 34677

Rev. 04/2025

Kesin Pharma LogoKesin Pharma Logo

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Docusate Sodium 10 mL Case Label x 100 UDCDocusate Sodium 10 mL Case Label x 100 UDC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN1
1248119docusate sodium 10 MG/ML Oral SuspensionSCD1
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY1
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY1
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY1
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-022-10Docusate Sodium Oral Liquid10 mL in 1 CUP, UNIT-DOSELIQUID101
81033-022-50Docusate Sodium Oral Liquid100 in 1 CASELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-022DOCUSATE SODIUM ORAL LIQUID LIQUID [KESIN PHARMA CORPORATION]1Current NDC, 2 package rows20250427_331277b8-8304-d082-e063-6394a90a4dd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-022-10ML - Milliliter81033-022592e48d2-2f24-4f2f-b824-d15fadcaf4be12025-05-14
81033-022-50ML - Milliliter81033-0222088ee40-f975-4ca9-b2a3-65a3d197142812025-05-14

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81033-02281033-022-10, 81033-022-50
84447-011

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
SUCRALOSE96K6UQ3ZD4IACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
POTASSIUM CITRATEEE90ONI6FFIACT
SORBITOL506T60A25RIACT
GRAPE6X543N684KIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
METHYLPARABENA2I8C7HI9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate SodiumDOCUSATE SODIUMBelleview Bio Science335f41d7-5c22-7c17-e063-6294a90a8f282025-04-22WarningsExact identifier
ndc (product): 84447-011
Docusate Sodium Oral LiquidDOCUSATE SODIUM ORAL LIQUIDKesin Pharma Corporation331277b8-8304-d082-e063-6394a90a4dd32025-04-18WarningsExact identifier
ndc (package): 81033-022-50
ndc (package): 81033-022-10
ndc (product): 81033-022
ndc11 (package): 81033002210
ndc11 (package): 81033002250
spl id: 331277b8-8305-d082-e063-6394a90a4dd3
spl set id: 331277b8-8304-d082-e063-6394a90a4dd3

Reported adverse events (FAERS/openFDA)#

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