Active Ingredient (In Each Tablet)
Sennosides 25 mg
Maximum Strength Senna Laxative Tablet
FDA Label NDC 84324-033
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuvicare Llc for the product Maximum Strength Senna Laxative (NDC 84324-033). 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:, directions, other information, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant Laxative
Uses:
- relieves occasional constipation (irregularity).
- generally prodcues a bowel movement in 6-12 hours
Warnings:
Do not use
- laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
Directions
- swallow tablet (s) with a glass of water.
- swallow tablet (s) whole, do not crush, break or chew.
- adults and children 12 years of age and older: 2 tablets once or twice daily
- children 6 to under 12 years of age: 1 tablet once or twice daily
- children under 6 years of age: ask a doctor
Other Information
- each tablet contains: Calcium 27 mg, Magnesium 0.16 mg, Sodium 0.81 mg
- store at controlled room temperature 20-25°C (68-77°F)
Inactive Ingredients
Microcrystalline Cellulose, Dicalcium Phosphate/Dibasic Calcium Phosphate, Croscarmellose Sodium, Sodium Lauryl sulphate, Colloidal Silicon Dioxide, Crospovidone, Stearic acid powder, Magnesium Stearate, Brilliant Blue Lake, Indigo Carmine Lake, Polyvinly Alcohol, Polyethylene Glycol, Titanium Dioxide, Talc
Questions Or Comments?
Call 1 (718) 337-8733 or email: [email protected]
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