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  5. Label Information: Docusate Sodium Liquid

FDA Label for Docusate Sodium Liquid

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. OTC - QUESTIONS
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium Liquid Product Label

The following document was submitted to the FDA by the labeler of this product Llorens Pharmaceuticals International Division. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients (per 5 mL)

Docusate Sodium 50 mg


Otc - Purpose



Purpose

Stool Softener


Indications & Usage



Uses

Relief of occasional constipation


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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidental overdose, seek medical assistance or contact a Poison Control Center right away.


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



Inactive ingredients: FD&C red #40, flavor, methylparaben, poloxamer, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate, sodium citrate, sucralose


Otc - Questions



Questions or comments? 1-866-595-5598


Package Label.Principal Display Panel



DocusateSodium - Ducosate

DocusateSodium - Ducosate


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