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| Product NDC Code | 41415-121 | ||||
|---|---|---|---|---|---|
| Drug Name | Publix women laxative |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 308753 | ||||
| Application Number | M007 | ||||
| Labeler Name | PUBLIX SUPER MARKETS, INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Bisacodyl, USP 5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C Red No. 7 calcium lake, 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use ▪ for relief of occasional constipation (irregularity) ▪ this product generally produces a bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Laxative
Spl product data elements
Usually a list of ingredients in a drug product.Publix Women Laxative Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA CALCIUM SULFATE ANHYDROUS ANHYDROUS LACTOSE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C RED NO. 7 HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST) FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW KAOLIN MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED SHELLAC SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID RAW SUGAR TALC TITANIUM DIOXIDE TRIACETIN RP121
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Product Label Woman Laxative Stimulant Biscodyl
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information ▪ each tablet contains: calcium 20 mg ▪ store at room temperature ▪ keep this carton for future reference on full labeling.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have ▪ abdominal pain ▪ nausea ▪ vomiting ▪ a sudden change in bowel habits that lasts more than 2 weeks
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for children under 6 years of age.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-267-3037
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnancy or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API