Otc - Purpose
| Active ingredientes (in each tablet) | Purpose |
| Bisacodyl 5 mg ......... | Stimulant laxative |
Laxomil Tablet, Coated
FDA Label NDC 55758-504
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Laxomil (NDC 55758-504). 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 otc - 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 pregnant or breast-feeding,, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use
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. These tablets should not be chewed because gastric irritation may occur.
Ask A Doctor Before Use If You Have
- abdominal pain, nausea, or vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When Using This Product
- take this product 2 hours before or after other drugs
- do not take this product within 1 hour after taking an antacid or milk
Stop Use And Ask A Doctor If
- you need to use for more than 7 days
- rectal bleeding occurs
- you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.
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
- take with plenty of water
- do not chew or crush tablet(s)
| Age | Dose |
| adults and children 12 years and older | take 1 to 3 tablets in a single dose, once a day |
| children 6 to undee 12 years | take 1 tablet once a day |
| children under 6 years | consult a doctor |
Other Information
- store between 68-77°F (20-25°C)
- do not use if seal under cap is torn, broken or missing
Inactive Ingredients
D&C yellow #10, FD&C yellow #6, hypromellose, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium starch glycolate type A, talc, titanium dioxide,triethyl citrate, water
Questions?
+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Dist. By/ Por:
Pharmadel LLC
New Castle, DE 19720
+1-866-359-3478
www.pharmadel.com
* Please review the disclaimer below.
