Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Dr Simi Regular Strength Sennosides 8.6mg Tablet, Coated
FDA Label NDC 85786-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Farmacias De Similares Tx Llc for the product Dr Simi Regular Strength Sennosides 8.6mg (NDC 85786-501). 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 (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces a bowel movement in 6-12 hours
Warnings
Warnings
Do Not Use
- laxative products for longer than 1 week unless directed by a 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
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.
If Pregnant Or Breast-Feeding
ask a health professional before use.
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.
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 Information
- Each tablet contains: calcium 20 mg
- Store in a dry place at 15° - 30C (59° - 86°F)
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, talc.
Questions Or Comments?
855-280-1079
Other
*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Senokot®.
Distributed by:
FARMACIAS DE SIMILARES TX LLC
800 Brazos St Ste 260, Austin, TX, 78701, USA
[email protected]
www.drsimi.com
Package Label.Principal Display Panel
Label (Sennosides)
NDC: 85786-501-50
Compare to Senokot® Regular Strength active ingredient*
Regular Strength
Sennosides 8.6 mg
Laxative
Standardized Senna Concentrate Natural Vegetable Laxative Ingredient
50 tablets
* Please review the disclaimer below.
