FDA Label for Bisacodyl
View Indications, Usage & Precautions
Bisacodyl Product Label
The following document was submitted to the FDA by the labeler of this product Apnar Pharma Lp. 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.
Otc - Active Ingredient
Active ingredient (in each tablet)
Bisacodyl (USP) 5 mg
Otc - Purpose
Purpose
Stimulant laxative
Indications & Usage
​Uses
- for relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
Warnings
Warnings
Do not use
- if you cannot swallow without chewing
- stomach pain, nausea, or vomiting
- noticed a sudden change in bowel habits that lasts more than 2 weeks
- it may cause stomach discomfort, faintness and cramps
- do not chew or crush tablets(s)
- do not use within 1 hour after taking antacid or milk
- you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
Ask a doctor before use if you have:
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding,
ask a health care professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- take with glass of water
- adult and children 12 years of age and over- 1 to 3 tablets in a single daily dose
- children 6 to under 12 years of age- 1 tablet in a single daily dose
- children under 6 years of age- ask a doctor
Storage And Handling
Other Information
- store at 15°-30°C (59° - 86° F).
Inactive Ingredient
Inactive ingredients
Lactose monohydrate, Anhydrous lactose, Pregelatinized starch, Magnesium stearate, Hypromellose, Triacetin, Talc, Methacrylic acid-ethyl acrylate copolymer (1:1) Type-A, Titanium dioxide, Triethyl citrate, D&C red no. 27, Colloidal anhydrous silica, Sodium bicarbonate, Sodium lauryl sulfate, FD&C blue no. 1, Carboxymethyl cellulose sodium, Maltodextrin, Dextrose monohydrate, Lecithin Soya.
Otc - Questions
Questions or comments?
- 1-855-642-2594
Other
Distributed By:
APNAR PHARMA LP
CHINO, CA, 91710
Rev.: 07/2022
Compare to Dulcolax Pink®
active ingredient*
*This product is not maufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark of Dulcolax Pink ®
Boxed Warning
Caution: Do not use if imprinted seal under cap is broken or missing.
Package Label.Principal Display Panel
NDC 24689-129-02
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
20 Tablets
NDC 24689-129-03
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
100 Tablets
NDC 24689-129-04
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
250 Tablets
NDC 24689-129-05
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
500 Tablets
* Please review the disclaimer below.