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  5. Label Information: Docusate Sodium 50 Mg

FDA Label for Docusate Sodium 50 Mg

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL - SHIPPING LABEL

Docusate Sodium 50 Mg Product Label

The following document was submitted to the FDA by the labeler of this product Humanwell Puracap Pharmaceutical (wuhan), Ltd.. 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.

Other



Drug Facts


Active Ingredient (In Each Softgel)



Docusate Sodium 50 mg


Purpose



Stool softener


Uses



  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Do Not Use



  • if you are presently taking mineral oil, unless told to do so by a doctor                                   

Ask A Doctor Before Use If You Have



  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop Use And Ask A Doctor If



  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

Directions



Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

Adults and children 12 years of ages and over

take 1 to 6 softgels daily

Children 2 and under 12 years of age

take 1 to 3 softgels daily

children under 2 years of age

ask a doctor


Other Information



  • each softgel contains: sodium 3 mg VERY LOW SODIUM
  • store at 15°-30°C (59°-86°F)

    Keep tightly closed.


Inactive Ingredients



citric acid, D&C red #33, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

Manufactured by:
Humanwell PuraCap Pharmaceutical (Wuhan) Ltd.
Wuhan, Hubei
430206, China


Principal Display Panel - Shipping Label



 

DOCUSATE SODIUM CAPSULES, 50 mg

Quantity : 20000 Capsules
NDC. No : 53345-015-01

IMPORTANT:

Inspect immediate upon receipt.
This is a bulk shipment intended for further processing only.
Protect from heat, humidity, and light. Do not refrigerate.

CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING"

 


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