Active Ingredient (In Each Tablet)
Bisacodyl, USP 5 mg
Publix Women Tablet
FDA Label NDC 41415-121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets, Inc for the product Publix Women (NDC 41415-121). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Use
▪ for relief of occasional constipation (irregularity)▪ this product generally produces a bowel movement in 6 to 12 hours
Do Not Use
for children under 6 years of age.
Ask A Doctor Before Use If You Have
▪ abdominal pain▪ nausea▪ vomiting▪ a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
▪ do not chew or crush tablet▪ do not use within 1 hour after taking an antacid or milk▪ abdominal discomfort, faintness and cramps may occur
Stop Use And Ask A Doctor If
▪ you need to use a laxative for more than 1 week▪ rectal bleeding or failure to have a bowel movement after use of laxative. These could be signs of a serious condition.
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 at (1-800-222-1222).
Directions
▪ each laxative works differently. Adults and children over 12 may need fewer tablets to get the same effect as more tablets of another brand.▪ start with one tablet and take with water. If one tablet does not produce the desired results, then try two or three tablets daily.▪ do not take more than three tablets daily
adults and children 12 years of age and older | take 1 to 3 tablets in a single dose once daily |
children 6 to under 12 year of age | take 1 tablets once daily |
children under 6 years of age | ask a doctor |
Other Information
▪ each tablet contains: calcium 20 mg▪ store at room temperature▪ keep this carton for future reference on full labeling.
Inactive Ingredients
acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C Red No. 7, hypromellose phthalate, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin.
Questions Or Comments?
1-888-267-3037
Principal Display Panel
NDC# 41415-121-30
*Compare to the Correctol® active ingredient
WOMEN’S laxative
BISACODYL, USP 5 mg
STIMULANT LAXATIVE
- For gentle, overnight relief from irregularity
30 TABLETS
*This product is not manufactured or distributed by Schering Plough Healthcare Products, Inc., owner of the registered trademark Correctol®.
TAMPER EVIDENT: DO NOT USE IF ANY INDIVIDUAL BLISTER IS BROKEN OR OPEN.
IMPORTANT: Keep this carton for future reference on full labeling. |
DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811
1-888-267-3037 publix.com
PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUE MONEY BACK
* Please review the disclaimer below.
