Docusate Sodium Liquid

Manufacturer
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:30:03

Label at a glance#

ProductDocusate Sodium Liquid
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

OTC - PURPOSE SECTION

Purpose

Stool Softener

INDICATIONS & USAGE SECTION

Uses

Relief of occasional constipation

WARNINGS SECTION

Warnings

Do not use when

  • abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for more than one week unless directed by a doctor

Ask a doctore before use if you

  • are taking mineral oil
  • have noticed a sudden change in bowel habits that last more than two weeks

Stop use and ask doctor if

  • you have no bowel movements 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 doctor before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • follow dosing directions below or use as directed by a physician
  • must be given in a 6 oz to 8 oz glass of milk or fruit juice to prevent throat irritation
  • may be taken as a single daily dose or in dividend dose
  • 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

1 teasponnful = 5 mL

 Age Dose
 Adults and children over 12 years of age 1 to 6 teaspoons (50 mg - 300 mg)
 Children under 12 years of age Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose

OTC - QUESTIONS SECTION

Questions or comments? 1-866-595-5598

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DucosateDucosate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN9
1248119docusate sodium 10 MG/ML Oral SuspensionSCD9
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY9
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY9
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY9
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY9

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-813-16Docusate Sodium Liquid473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-813-16ML - Milliliter54859-81325502fa9-6f5b-4d15-898f-034a45e4599b12025-05-14

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
54859-81354859-813-16

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
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact identifier
ndc (package): 54859-813-16
ndc (product): 54859-813
ndc11 (package): 54859081316
spl id: 4745fe35-8aba-b427-e063-6394a90ab073
spl set id: 2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c

Reported adverse events (FAERS/openFDA)#

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