Docusate Sodium Liquid
Docusate Sodium Liquid
b23ad877-644d-4fde-bb2e-a6b8a22966da
HUMAN OTC DRUG LABEL
May 27, 2025
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
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Uses
Relief of occasional constipation
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (per 5 mL)
Docusate Sodium 50 mg
OTC - PURPOSE SECTION
Purpose
Stool Softener
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