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  5. Label Information: Docusate Sodium With Sennosides

FDA Label for Docusate Sodium With Sennosides

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. 16 HOW SUPPLIED/STORAGE AND HANDLING
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Sodium With Sennosides Product Label

The following document was submitted to the FDA by the labeler of this product Pd-rx Pharmaceuticals, Inc.. 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.

Active Ingredients (In Each Tablet)



Sennosides from Senna Concentrate 8.6mg

Docusate Sodium 50mg


Purpose



Laxative

Stool Softner


Uses



  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 6-12 hours

Warnings



Do not use

  • laxative products for longer than 1 week unless directed by a doctor
  • if you are taking mineral oil, unless directed by a doctor

Ask A Doctor Before Use If You Have



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

Stop Use And Ask A Doctor If



you have rectal bleeding or fail to have a bowel movement after the use of a laxative. These may indicate a serious condition.


If Pregnant Or Breast Feeding,



ask a healthcare professional before use. 


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.(800) 222-1222.


Directions



  • take preferably at bedtime or as directed by a doctor

    • age

    starting dosage

    maximum dosage

    Adults and children 12 years and over

    2 tablets once daily

    4 tablets twice daily

    Children 6 to under 12 years

    1 tablet once daily

    2 tablets  twice daily

    Children 2 to under 6 years 

    1/2 tablet  once daily

    1 tablet twice daily

    Children under 2 years

    ask a doctor

    ask a  doctor


Other Information



  • each tablet contains 10 mg of calcium, sodium 5 mg
  • store at 25°(77°F); excursions permitted between 15 o-30 oC (59 o-86 oF)

Inactive Ingredients



crosscarmellose Sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide


Questions Or Comments?



(866) 562-2756 Mon-Fri 8 AM to 4 PM EST


16 How Supplied/Storage And Handling



Docusate Sodium with Sennosides is a orange, round tablet; Debossed with PH32.

Bottles of 100                                           NDC 43063-958-01

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).


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