Otc - Purpose
Relieves mild irritation caused by shellfish and seafood
Allergyease Shellfish And Seafood
FDA Label NDC 68703-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Native Remedies, Llc for the product Allergyease Shellfish And Seafood (NDC 68703-124). 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 otc - purpose, otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Drug Facts
Active Ingredients: Adrenalinum, Belladona, Bromium, Carbo animalis, Colchicum autumnale, Colocynthis, Histaminum hydrochloricum, Hydrstis canadensis, Kali carbonicum, Lycopodium clavatum, Mercuris solubilis, Pulsatilla, Urtica urens
Indications & Usage
Uses:For temporary relief of symptoms from shellfish and seafood: indigestions, diarrhea, nausea, sinus congestion, headaches, skin irritations, and abdominal cramps
Warnings
Warnings: Stop use and ask a doctor if symptoms persist or worsen
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep this and all medications out of reach of children
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away. NOTE: For severe allergy symptoms consult your physician. NOT intended as a substitute for standard medical care; intended to complement prescribed medication
Dosage & Administration
Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed. Adults: 3 pumps sprays. Children 2-12:2 pump sprays
Inactive Ingredient
Inactive Ingredients: Citric acid, potassium sorbate, pure water
Information For Patients
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International: 1.561.999.8857
No gluten, artificial flavors, or colorants added
Storage And Handling
Tamper resistant for your protection. Use only if safety seal is intact
Package Label.Principal Display Panel
Bottle Label (Asf001)
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