FDA Label for Leader Gentle Laxative
View Indications, Usage & Precautions
Leader Gentle Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health, 110 Dba Leader. 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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