FDA Label for Womens Gentle Laxative
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Womens Gentle Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Chain Drug Consortium. 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 5 mg
Purpose
Stimulant laxative
Uses
- for the relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Warnings
Do Not Use
if you are unable to swallow without chewing.
Ask A Doctor Before Use If You Have
- abdominal pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When Using This Product
- abdominal discomfort, faintness, and cramps may occur
- do not use for a period longer than 1 week unless directed by a doctor
Stop Use And Ask A Doctor If
rectal bleeding or failure to have a bowel movement occurs after use of a laxative.
These may be signs of a serious condition.
If Pregnant 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 (1-800-222-1222) right away.
Directions
- do not chew or crush tablets
- do not take within 1 hour after taking an antacid or milk
- take with water
- adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily
- children under 12 years: ask a doctor
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER UNIT IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 68016-197-30
*COMPARE TO THE ACTIVE INGREDIENT IN CORRECTOL®
Premier
Value®
Women's
Gentle Laxative
Bisacodyl 5 mg
STIMULANT LAXATIVE
Gentle, dependable
overnight relief
30 Tablets
Enteric coated tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Correctol®.
50844 ORG051567601
DISTRIBUTED BY
CHAIN DRUG CONSORTIUM, LLC
UPARC, BLDG. A3, SUITE 338, 1020 WILLIAM PITT WAY
PITTSBURGH, PA 15238
www.chaindrugconsortium.com
* Please review the disclaimer below.