Otc - Active Ingredient
ACTIVE INGREDIENTS: Echinacea purpurea 2X, Plantago major 2X, Baptisia tinctoria 3X, Phytolacca decandra 3X, Apil mellifica 12X, Belladonna 12X, Lachesis mutus 12X, Mercurius solubilis 12X, Hepar sulphuris calcareum 15X.
Sore Throat
FDA Label NDC 57520-0157
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Sore Throat (NDC 57520-0157). 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 - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - questions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INDICATIONS: For the symptomatic relief of monor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.
Warnings
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more that two days or administer to children under 3 years of age unless directed by a physician.
Recommended for Professional Use.
Dosage & Administration
DIRECTIONS: Adults and children over 12 years of age, at onset of symptoms, spray throat every 3 hours. Consult a physician for use in children under 12 years of age.
To be used according to standard homeopathic indications or as directed by a homeopathic physician.
Inactive Ingredient
INACTIVE INGREDIENTS: Demineralized water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow flavor, Menthol, Spearmint oil, Stevia 90% Powered Extract, Teaberry oil.
Otc - Questions
Manufactured Exclusively For:
NSI and Nova Aurora Corp
Pittsburgh, PA 15209
www.phpltd.com
Package Label.Principal Display Panel
PROFESSIONAL HEALTH PRODUCTS
SORE THROAT SPRAY
HOMEOPATHIC
C63 (reorder code)
NET 1 FL. OZ. (30 ML)
Sore Throat Spray (Mm1)
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