Active Ingredients:
Echinacea Purpurea 2X, Plantago Major 2X, Baptisia Tinctoria 3X, Phytolacca Decandra 3X, Apis Mellifica 12X, Belladonna 12X, Lachesis Mutus 12X, Mercurius Solubilis 12X, Hepar Sulphuris Calcareum 15X.
Sore Throat Spray
FDA Label NDC 53173-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nova Aurora Corp for the product Sore Throat (NDC 53173-0001). 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 active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.
For the temporary symptomatic relief of minor pain associated with sore throat, difficulty swallowing, speaking, hoarseness or canker sores.
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 than two days or administer to children under 3 years of age unless directed by a physician.
Recommended for Professional Use.
Keep Out Of Reach Of Children:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
Adults and children over 12 years of age, at the onset of symptoms, spray throat every 3 hours. Consult a physician for use in children under 12 years of age.
Inactive Ingredients:
Demineralized Water, 23% Ethanol, Glycerin, Herbal Base [Clove (Flower), Goldenseal (Root), Myrrh (Resin), Sage (Leaf), Thyme (Leaf)], Marshmallow Flavor, Menthol, Spearmint Oil (flowering tops), Stevia (leaf) Extract, Teaberry Oil Flavor.
Questions:
Manufactured Exclusively For:
NSI and Nova Aurora Corp
P.O. Box 97227
Pittsburgh, PA 15209
www.phpltd.com
Package Label Display:
PROFESSIONAL HEALTH PRODUCTS
SORE THROAT
SPRAY
HOMEOPATHIC
C63 (reorder code)
NET 1 FL. OZ. (30 ML)
* Please review the disclaimer below.
