FDA.reportPublic FDA data

Docusate Sodium

Manufacturer
Belleview Bio Science
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:30

Label at a glance#

ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure10 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 10 mL)

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 persist 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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OVERDOSAGE SECTION

In case of overdosage, 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 20ºC to 25ºC (68ºF to 77ºF)
  • 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

BULK SHIPMENT: For institutional or repackaging use only.

Docusate Sodium Liquid

50 mg per 5 mL

200,00 mL

NDC: 8447-011-01

Docusate Sodium Bulk LabelDocusate Sodium Bulk Label

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-011-01Docusate Sodium200000 mL in 1 DRUMLIQUID2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84447-011DOCUSATE SODIUM LIQUID [BELLEVIEW BIO SCIENCE]1Current NDC, 1 package rows20250424_335f41d7-5c22-7c17-e063-6294a90a8f28.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84447-01184447-011-01

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
PROPYLPARABENZ8IX2SC1OHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
POTASSIUM CITRATEEE90ONI6FFIACT
SUCRALOSE96K6UQ3ZD4IACT
GRAPE6X543N684KIACT
SORBITOL506T60A25RIACT
AMMONIUM GLYCYRRHIZATE3VRD35U26CIACT
WATER059QF0KO0RIACT
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 · 1 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 (package): 84447-011-01
ndc (product): 84447-011
ndc11 (package): 84447001101
spl id: 335f41d7-5c23-7c17-e063-6294a90a8f28
spl set id: 335f41d7-5c22-7c17-e063-6294a90a8f28

Reported adverse events (FAERS/openFDA)#

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