Docusate Sodium Liquid

Manufacturer
Geritrex LLC | RIJ Pharmaceutical Corporation
Effective date
2017-09-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:38

Label at a glance#

ProductDocusate Sodium Liquid
Active ingredientDocusate sodium
Label structure9 sections

Indications and uses

prevents / relieves dry hard stool results usually occur 1 to 3 days after the first dose

Dosage and administration

follow dosing directions below or take as directed by doctor must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation may be taken as a single daily dose or in divided doses take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response do not exceed recommended dose shake well before using Adults and children 12 years and over 1 to ...

Label contents#

Full prescribing information#

Active Ingredient (per teaspoonful = 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg

Purpose

OTC - PURPOSE SECTION

Stool Softener

Uses

INDICATIONS & USAGE SECTION

  • prevents / relieves dry hard stool
  • results usually occur 1 to 3 days after the first dose

Warnings

WARNINGS SECTION

Do not use
  • when abdominal pain, nausea, or vomiting are present
  • for more than one week unless directed by a doctor
Ask a doctor before use if you
  • are taking mineral oil
  • have noticed a sudden change in bowel habits that lasts more than 2 weeks
Stop use and ask a doctor if
  • you have no bowel movement within 3 days
  • you have rectal bleeding
  • these could be signs of a serious condition
  • a skin rash occurs
  • you experience throat irritation

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, seek professional assisstance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • follow dosing directions below or take as directed by doctor
  • must be given in a 6 to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in divided doses
  • take maximum dose daily until first bowel movement, dosage should then be reduced according to individual response
  • do not exceed recommended dose
  • shake well before using
Adults and children 12 years and over1 to 6 teaspoons (50 to 300 mg)
Children 2 to 12 years of age1 to 3 teaspoons (50 to 150 mg)

1 teaspoon = 5 mL

TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing.


Other information

  • Store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive heat
  • Keep tightly closed
  • Dispense in tight, light resistant container as defined in the USP
  • each teaspoon (5 mL) contains: sodium 15 mg

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, D&C Red #33, flavor, methylparaben, parabens, poloxamer, polyethylene glycol 400, propylparaben, sodium citrate, sorbitol, sucrose, and water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-195-162020-01-31C16284748780-19d75b9d0-e401-f424-e053-dadaa90a57ceDocusate Sodium Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-195-16Docusate Sodium Liquid473 mL in 1 BOTTLE, PLASTICLIQUID4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-195DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [GERITREX LLC]1Legacy NDC, 1 package rows20171006_4d022ef5-fa76-4e50-b56b-759bc35754ab.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-195-16ML - Milliliter54162-195770e890c-0030-4f83-af1a-9754e475429112018-01-12

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
54162-19554162-195-16

Ingredients#

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

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

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
6b770ed5-fd3f-4797-a693-6724b73c77584d022ef5-fa76-4e50-b56b-759bc35754ab2017-09-28WarningsExact identifier
spl id: 6b770ed5-fd3f-4797-a693-6724b73c7758
spl set id: 4d022ef5-fa76-4e50-b56b-759bc35754ab

Reported adverse events (FAERS/openFDA)#

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