Other
DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Drug Facts
Manufactured for:
Alexso Inc.
Los Angeles, CA 90064
Distributed by:
Advanced Rx Pharmacy of Tennessee, LLC
Laxacin Tablet
FDA Label NDC 80425-0345
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Pharmacy Of Tennessee, Llc for the product Laxacin (NDC 80425-0345). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients (in each tablet)
Docusate Sodium 50 mg
Sennosides 8.6 mg
Otc - Purpose
Purposes
Stool softener
Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
Warnings
Warnings
Otc - Do Not Use
Do not use
- if you are now taking mineral oil, unless directed by a doctor
- laxative products for longer than 1 week unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues over a period of 2 weeks
Otc - Stop Use
Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health 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 preferably at bedtime or as directed by a doctor
age | starting dose | maximum dose |
adults and children 12 years and older | 2 tablets once a day | 4 tablets twice a day |
children 6 to under 12 years | 1 tablet once a day | 2 tablets twice a day |
children 2 to under 6 years | 1/2 tablet once a day | 1 tablet twice a day |
children under 2 years | ask a doctor | ask a doctor |
Storage And Handling
Other information
- each tablet contains: calcium 20 mg, sodium 4 mg
- keep lid tightly closed
- store at room temperature in a dry place
Inactive Ingredient
Inactive ingredientsCroscarmellose sodium, D&C yellow #10, dextrose, dicalcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silica, sodium benzoate, stearic acid, titanium dioxide.
Otc - Questions
Questions?If you have any questions or comments, or to report an adverse event, please contact (800) 495-6078
How Supplied
Laxacin tablets are supplied as follows:
Bottles of 100 tablets NDC: 80425-0345-01
Package Label.Principal Display Panel
* Please review the disclaimer below.
