Active Ingredient (In Each Tablet)
Sennosides 8.6 mg
Senna Laxative Tablet
FDA Label NDC 80136-434
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Heartland Pharma Co. for the product Senna Laxative (NDC 80136-434). 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, otc - keep out of reach of children, directions, other information, inactive ingredients, 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 bowel movement in 6 to 12 hours
Warnings
Do not use for more than one week unless directed by a doctor.
Ask a doctor before use if you have
• stomach pain, nausea or vomiting
• noticed a change in bowel habits that lasts over two 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.
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.
Directions
• if taking the starting dosage,
take preferably at bedtime; or as directed by
a doctor. • If taking the maximum dosage,
take in the morning and at bedtime.
| Age
| Starting Dose
| Maximum Dose
|
|---|---|---|
| adults and children 12 years of age and older
| 2 tablets once a day | 4 tablets
twice a day |
| children 6
to under 12 years | 1 tablets once a day | 2 tablets
twice a day |
| children 2
to under 6 years | 1/2 tablets once a day | 1 tablets
twice a day |
| children
to under 2 years | Ask a doctor | Ask a doctor |
Other Information
- each tablet contains: calcium 40 mg
- store at 20°C-25°C (68°F-77°F)
Inactive Ingredients
croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica. May also contain wax.
Package Label
1 (434hpc)
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