FDA Label for Laxative
View Indications, Usage & Precautions
Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Publix Super Markets Inc. 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
Uses
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Do Not Use
if you cannot swallow without chewing.
Ask A Doctor Before Use If You Have
- a sudden change in bowel habits that lasts more than 2 weeks
- stomach pain, nausea or vomiting
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 fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
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 right away.
Directions
- do not take more than directed
- take with a glass of water
adults and children 12 years and over | take 1 to 3 tablets in a single daily dose |
children 6 to under 12 years | take 1 tablet in a single daily dose |
children under 6 years | ask a doctor |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- avoid excessive humidity
- 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
carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate
Principal Display Panel
NDC 56062-976-01
P
laxative
BISACODYL USP, 5 mg
STIMULANT LAXATIVE
• Gentle, dependable constipation relief
30
COMFORT
COATED TABLETS
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0923A67601
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811
1-888-267-3037 publix.com
PUBLIX GUARANTEE: COMPLETE
SATISFACTION OR YOUR MONEY BACK
Publix®
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