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
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 12, 2021
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- Official Label (Printer Friendly)
- 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 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) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) 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 not final part334 12/01/2021 Labeler - LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION (037342305)
