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  5. Label Information: Docusate Sodium 100mg Two-tone

FDA Label for Docusate Sodium 100mg Two-tone

View Indications, Usage & Precautions

Table of Contents

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

Docusate Sodium 100mg Two-tone 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 100 mg


Purpose



Stool softener 


Uses



  • relieves occasional constipation (irregularity)
  • generally produces a 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

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 and over		 take 1 to 3 softgels daily
 children 2 to under 12 years of age take 1 softgel daily
 children under 2 years ask a doctor


Other Information



  • each softgel contains: sodium 5 mg
  • VERY LOW SODIUM
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive Ingredients



Black ink, citric acid, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special and purified water


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


Principal Display Panel - Shipping Label



DOCUSATE SODIUM CAPSULES, 100 mg

Quantity : 15000 Capsules
NDC. No : 53345-023-02

IMPORTANT:

  • Inspect immediate upon receipt.
  • This is a bulk shipment, intended for further processing only.
  • Protect from heat, humidity, and light. Do not refrigerate.
  • Store at 15-30°C (59-86°F)

    • CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING


* Please review the disclaimer below.