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  5. Label Information: Leader Senna Laxative

FDA Label for Leader Senna Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS - DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREASTFEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    14. PRODUCT LABELING

Leader Senna Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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 8.6mg


Purpose



Stool softener
Stimulant Laxative


Uses



  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12hours.

Warnings - Do Not Use



  • laxative products for longer than 1 week 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 movements that continues over a period of 2 weeks.

Stop Use And Ask A Doctor If



  • you have rectal bleeding
  • you fail to have a bowel movement after use. These could be signs of a serious condition

If Pregnant Or Breastfeeding



ask a health professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



Take preferably at bedtime or as directed by a doctor

                                                                                     age; starting dosage; maximum dosage

  • adults and children 12 years of age: 2 tablets once a day; 4 tablets twice a day.
  • children 6 to under 12 years of age: 1 tablet once a day; 2 tablets twice a day
  • children 2 to under 6 years of age:   1/2 tablet once a day; 1 tablet twice a day
  • children under 2: ask a doctor; ask a doctor

Other Information




  • each tablet contains: calcium 25mg/tablet
  • store at 25C (77F); excursions permitted between 15 - 30 degrees C (59-86 degrees F)
  • do not use if imprinted safety seal under cap is broken or missing.
  • *This product is not manufactured or distributed by Purdue Products, LP, owner of the registered trademark Senokot.

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, *dicalcium phosphate anhydrous, hypromellose, maltodextrin, magnesium stearate, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG), stearic acid, talk, triacetin. *May also contain.


Questions Or Comments?



call toll free:1-800-200-6313


Package Label.Principal Display Panel



Comapre to Senokot active ingredient *

Leader

Senna Laxative
Sennosides, 8.6mg

Natural Vegetable Laxative for Relief of Constipation
100 Tablets

Distributed by Cardinal Health
Dublin, Ohio 43017
CIN 1382639

www.myleader.com
1-800-200-6313

All Leader Brand Products are 100% satisfaction guaranteed or return to place of purchase for a full refund.


Product Labeling



Stool Softener - sennalaxative

Stool Softener - sennalaxative


* Please review the disclaimer below.