Docusate Sodium Liquid

Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:37

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

DISTRIBUTED BY 

ATLANTIC BIOLOGICALS CORP

MIAMI, FL 33179

OTC - QUESTIONS SECTION

Questions or comments? 1-800-509-7592

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN4
1248119docusate sodium 10 MG/ML Oral SuspensionSCD4
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY4
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY4
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY4
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY4

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-1304-1Docusate Sodium Liquid25 mL in 1 CUP, UNIT-DOSELIQUID254
17856-1304-1Docusate Sodium Liquid50 in 1 BOX, UNIT-DOSELIQUID504
17856-1304-2Docusate Sodium Liquid10 mL in 1 CUP, UNIT-DOSELIQUID104
17856-1304-2Docusate Sodium Liquid72 in 1 BOX, UNIT-DOSELIQUID724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-1304DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [ATLANTIC BIOLOGICALS CORP.]44 package rows20250529_b23ad877-644d-4fde-bb2e-a6b8a22966da.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1304-2ML - Milliliter17856-130465b6c009-811c-4db9-8461-38e9a67a798b12026-02-05

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
17856-130417856-1304-1, 17856-1304-2
0536-1304

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
ndc (product): 0536-1304
361f75a0-918b-4a5d-e063-6294a90ae813b23ad877-644d-4fde-bb2e-a6b8a22966da2025-05-27WarningsExact identifier
spl id: 361f75a0-918b-4a5d-e063-6294a90ae813
spl set id: b23ad877-644d-4fde-bb2e-a6b8a22966da

Reported adverse events (FAERS/openFDA)#

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