Indications & Usage
Directions: FOR ORAL USE ONLY.
Prunus Spinosa E Summ 10%
FDA Label NDC 48951-8082
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 Prunus Spinosa E Summ 10% (NDC 48951-8082). 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 Ingredient: 100 gm contains: 10gm Prunus spinosa e summ. MT
Inactive Ingredient
Inactive Ingredients: Distilled water, Organic cane alcohol
Otc - Purpose
Use: Temporary relief of fatigue.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Warnings
Warnings: 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.
Natural ingredients may cause color, scent and/or taste
variation.
Otc - Questions
Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
www.urielpharmacy.com
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