Label: DOCUSATE SODIUM LIQUID- docusate sodium liquid
- NDC Code(s): 54859-813-16
- Packager: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCUSATE SODIUM LIQUID
docusate sodium liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54859-813 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg in 5 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) POLOXAMER 124 (UNII: 1S66E28KXA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54859-813-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M007 12/01/2021 Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)