Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Senaklear Tablet, Film Coated
FDA Label NDC 57237-371
13 label sections · Submitted to the FDA by Rising Pharma Holdings, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Senaklear (NDC 57237-371). 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, ask a doctor before use if you have, 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
Purpose
Laxative
Uses
- for relief of occasional constipation (irregularity)
- generally produces a bowel movement in 6 to 12 hours
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 persists 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.
In case of overdose, get medical help or contact a Poison Control Center 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 | ½ 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 2 mg
- store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F)
Inactive Ingredients
Colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hypromellose 15, hypromellose 5, magnesium stearate, microcrystalline cellulose, paraffin liquid, sodium lauryl sulphate, stearic acid
Questions Or Comments?
call 1-844-474-7464
Package Label.Principal Display Panel
NDC 57237-371-99
Senaklear™
Sennoside Tablets, USP 8.6 mg
Regular Strength
Natural Vegetable Laxative Ingredient
1000 Tablets
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