Active Ingredient(S)
Bisacodyl USP 5mg
Womens Laxative Tablet, Sugar Coated
FDA Label NDC 69168-490
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Womens Laxative (NDC 69168-490). 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(s), purpose, use(s), do not use, ask a doctor before use if you, when using this product, stop use and ask a doctor before use if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant Laxative
Use(S)
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Do Not Use
- if you are unable to swallow without chewing
- within 1 hour after taking an antacid or milk
Ask A Doctor Before Use If You
- abdominal pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When Using This Product
- do not chew or crush tablets
- abdominal discomfort, faintness, and cramps may occur
Stop Use And Ask A Doctor Before Use If
- you need to use more than 1 week
- rectal bleeding or failure to have a bowel movement after use of a laxative.
These may be signs of a serious condition.
If Pregnant Or Breastfeeding,
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
- take with water
Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily
Children 6 to 12 years of age: take 1 tablet once a day
Children under 6 years of age: consult a doctor
Other Information
store between 68° to 77°F (20° to 25°C)
Inactive Ingredients
Acacia, Calcium Carbonate, Carnauba Wax, Colloidal Anhydrous
Silica, FD&C Red # 27 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Yellow #6
Aluminum Lake, Hypromellose, Iron Oxide Black, Lactose Anhydrous, Magnesium
Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer, Methylparaben, Polydextrose,
Polyethylene Glycol, Povidone, Pregelatinized Starch, Propylene Glycol, Propylparaben,
Shellac Glaze, Simethicone, Sodium Benzoate, Sodium Bicarbonate, Sodium Lauryl Sulfate,
Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate.
Questions/Comments
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