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Docusate Sodium Liquid

Docusate Sodium Liquid

Approved
Approval ID

b23ad877-644d-4fde-bb2e-a6b8a22966da

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Docusate Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code17856-1304
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Docusate Sodium
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (11)

FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLOXAMER 124Inactive
Code: 1S66E28KXA
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 50 mg in 5 mL
Code: F05Q2T2JA0
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/22/2023

1

2

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/22/2023

Uses

Relief of occasional constipation

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/22/2023

Active Ingredients (per 5 mL)

Docusate Sodium 50 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/22/2023

Purpose

Stool Softener

WARNINGS SECTION

LOINC: 34071-1Updated: 5/22/2023

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

LOINC: 53414-9Updated: 5/22/2023

If pregnant or breast-feeding, ask a doctor before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/22/2023

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

LOINC: 34068-7Updated: 5/22/2023

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

LOINC: 51727-6Updated: 5/22/2023

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

LOINC: 53413-1Updated: 5/22/2023

Questions or comments? 1-800-509-7592

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Docusate Sodium Liquid - FDA Drug Approval Details