1. Home
  2. Labeler Index
  3. Cardinal Health
  4. 70000-0441
  5. Label Information: Senna

FDA Label for Senna

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. OTC - QUESTIONS
    15. PRINCIPAL DISPLAY PANEL - LEADER™ REGULAR STRNGTH SENNA 60 SOFTGELS BOTTLE CARTON

Senna 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.

Other



Drug Facts

Drug Facts (continued)


Active Ingredient (In Each Softgel)



Sennosides 8.6 mg


Purpose



Laxative


Uses



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


Warnings



Warnings


Do Not Use



■ laxative products for longer than 1 week, 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 lasts over 2 weeks


Otc - Stop Use



Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after
use of a laxative. These may indicate a serious condition.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding,ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison
Control Center (1-800-222-1222) right away.


Directions



■ take preferably at bedtime or as directed by a doctor    

AgeStarting DosageMaximum Dosage
adults and children 12 years of age or over2 softgels once a day4 softgels twice a day 
children 6 to under 12 years1 softgel once a day2 softgels twice a day 
children under 6 years of ageask a doctor ask a doctor  


Other Information



■ each softgel contains: calcium 1 mg and sodium less than 1 mg
■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)


Inactive Ingredients



aerosil, beeswax, FD&C Blue No. 1, FD&C Red No.40, FD&C Yellow No. 6, gelatin, glycerin,
light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethyl cellulose,
sorbitol solution, soya lecithin, titanium dioxide


Otc - Questions



Questions or comments? 1-888-333-9792


Principal Display Panel - Leader™ Regular Strngth Senna 60 Softgels Bottle Carton



LEADER 

COMPARE TO
SENOKOT®
REGULAR
STRENGTH
active ingredient*
100% Money
Back Guarantee

NDC 70000-0441-1

Regular Strength

Senna

Sennosides, 8.6 mg | Laxative

Standardized
Senna Concentrate
Natural Vegetable Laxative Ingredient

60 SOFTGELS

Actual Size

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot® Regular Strength.


* Please review the disclaimer below.