FDA Label for Gentle Laxative Stimulant Laxative
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USE
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANCY OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Gentle Laxative Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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 Tablet)
Bisacodyl, USP 5 mg
Purpose
Stimulant laxative
Use
• for temporary relief of occasional constipation and irregularity• this product generally produces a bowel movement in 6 to 12 hours
Do Not Use
if you cannot swallow without chewing.
Ask A Doctor Before Use If You Have
• stomach pain, nausea or vomiting• a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
• do not chew or crush tablet(s)• do not use within 1 hour after taking an antacid or milk• it may cause stomach discomfort, faintness and cramps
Stop Use And Ask A Doctor If
• you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.• you need to use a laxative for more than 1 week
If Pregnancy Or Breast-Feeding,
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. (1-800-222-1222).
Directions
take with a glass of water
adults and children 12 years of age and over | take 1 to 3 tablets in a single daily dose |
children 6 to under 12 years of age | take 1 tablet in a single daily dose |
children under 6 years of age | ask a doctor |
Other Information
• store at 20-25°C (68°-77°F)• Protect from excessive humidity
Inactive Ingredients
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.
Questions Or Comments?
1-866-467-2748
Principal Display Panel
NDC# 63868-908-25
*Compare to the Active Ingredient in Dulcolax®
Gentle Laxative
Relieves Constipation & Irregularity
Bisacodyl, USP 5 mg
Relieves Constipation And Irregularity Overnight
Comfort-Coated Tablets For Gentle, Predictable Constipation Relief
25 TABLETS
100% QC SATISFACTION GURANTEED
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., the owner of the registered trademark Dulcolax®.
TAMPER EVIDENT: DO NOT USE IF any individual unit is broken or open.
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48376-0995
Questions: 248-449-9300
Product Label
QC(CDMA) Gentle Laxative
* Please review the disclaimer below.