The following Structured Product Label (SPL) was submitted to the FDA by New Sun Inc. for the product Bladder Incontinence Formula (NDC 66579-0078). 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 dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, otc - active ingredient, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.
Adult Dose: 3 Pump Sprays
Child's Dose (2-12): 2 Pump Sprays
Infants - 2 yrs: 1 Pump Spray
Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.
Keep out of reach of children.
Other information: Tamper resistant for your protection. Use only if safety seal is intact.
Indications: For temporary relief of: •involuntary urination •urinary leakage with strain, sneeze, or laughter •frequent urination •burning while urinating •associated back pain
Active Ingredients: Belladonna, Bellis perennis, Benzoicum acidum, Causticum, Equisetum hyemale, Lycopodium clavatum, Phosphorus, Plantago major, Rhus aromatica, Sepia. Equal volumes of each ingredient in 10X, 30X, 100X potencies.
Inactive Ingredient: Citric acid, potassium sorbate, purified water.
Indications: For temporary relief of:
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