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  5. Label Information: Leader Gentle Laxative

FDA Label for Leader Gentle Laxative

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SUPPOSITORY)
    2. USES
    3. WARNINGS
    4. DO NOT USE
    5. ASK A DOCTOR
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. PURPOSE
    14. QUTESTIONS?
    15. PRODUCT LABEL

Leader Gentle Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Major Pharmaceuticals. 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 Ingredient (In Each Suppository)



                                                                   Purpose

Bisacodyl USP, 10 mg.................................Stimulant Laxative


Uses



Uses - For temporary relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour


Warnings



For rectal use only.


Do Not Use



Do not use - more than once per day - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor- for a period of longer than one week unless directed by a doctor 


Ask A Doctor



Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks


When Using This Product



When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps


Stop Use And Ask A Doctor



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


If Pregnant Or Breast-Feeding



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


Keep Out Of Reach Of Children



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


Directions



Adults and children 12 years of age and older              Children 6 to under 12 years                 Children under 6

One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum, pointed end first

- Retain about 15 to 20 minutes


Other Information



Other information - Storage temperature: not to exceed 30oC (86oF)

- Lot No. & Exp. Date: see wrapper or box


Inactive Ingredient



Inactive ingredient  Hydrogenated vegetable oil


Purpose



Stimulant Laxative


Qutestions?



Questions? 1-724-733-7381


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