Indications & Usage
Directions: FOR ORAL USE ONLY.
Bryonia Spongia
FDA Label NDC 48951-2085
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Uriel Pharmacy Inc. for the product Bryonia Spongia (NDC 48951-2085). 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 indications & usage, dosage & administration, otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, warnings, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Take 3-4 times daily. Ages 12 and older: 10 drops. Ages 2-11: 5 drops. Under age 2: Consult a doctor.
Otc - Active Ingredient
Active Ingredients: Apis (Honeybee) 4X, Atropa belladonna (Nightshade) 4X, Bryonia (White bryony) 4X, Spongia (Sea sponge) 4X
Inactive Ingredient
Inactive Ingredients: Distilled water, Organic cane alcohol
Otc - Purpose
Use: Temporary relief of croupy cough.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
Otc - Questions
Questions? Call 866.642.2858 Made with care by Uriel, East Troy, WI 53120 www.urielpharmacy.com
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