Otc - Active Ingredient
Active Ingredients (in each tablet)
Docusate Sodium .................. 50 mg
Sennosides ........................... 8.6 mg
Healix Senna-s Tablet
FDA Label NDC 87275-2451
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brainstorm Industries Llc for the product Healix Senna-s (NDC 87275-2451). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - stop use, pregnancy, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Docusate Sodium ........ Stool Softener
Sennosides .......................... Laxative
Indications & Usage
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6 to 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 if you have
rectal bleeding or fail to have a bowel movement
after use of a laxative. These may indicate a serious condition.
Pregnancy
If pregnant or breastfeeding, 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 (1-800-222-1222) right away.
Dosage & Administration
Directions
Take preferably at bedtime or as directed by a doctor.
| AGE | STARTING DOSAGE | MAXIMUM DOSAGE |
| adults and children 12 years of age and over | 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 |
Other Safety Information
Other information
- each tablet contains: calcium 19.92 mg, sodium 5.61 mg
- store at 25°C (77°F); excursions permitted between 15°C-30°C (59°-86°F)
VERY LOW SODIUM
Inactive Ingredient
Inactive Ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, Dicalcium
Phosphate, FD&C Red, Hypromellose, Magnesium Stearate,
Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol 400,
Stearic Acid, Titanium Dioxide.
Otc - Questions
Questions?
Call 888-257-6600 or visit www.healixusa.com
Package Label.Principal Display Panel
Principal Display Panel
NDC 87275- 2451-10
Healix Senna+S Dual Action
Natural Vegetable Laxative Ingredient + Stool Softener
100 Tabletsin White Bottle
Sennosides 8.6 mg, Docusate Sodium 50 mg
* Please review the disclaimer below.
