Otc - Active Ingredient
Sennoside 8.6mg
Sennoside 8.6mg
FDA Label NDC 70692-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strive Pharmaceuticals Inc. for the product Sennoside 8.6mg (NDC 70692-112). 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, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, otc - purpose, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, magnesium stearate, polyethylene glycol
Dosage & Administration
- do not take more than directed
- take with full glass of water
- 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 |
Indications & Usage
- relieves occasional constipation (irregularity)
- generally causes a bowel movement in 6-12 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
- notice a sudden change in bowel habits that continue 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
Overdose Warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Incase of accidental overdose, get medical help or contact a Poison Contril Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Otc - Purpose
Laxative
Other Safety Information
- Store at room temperature between 20 °C - 25 °C (68 °F - 77 °F).
* Please review the disclaimer below.
