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  5. Label Information: Colds And Flu Response

FDA Label for Colds And Flu Response

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. INDICATIONS & USAGE
    4. DOSAGE & ADMINISTRATION
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. OTHER SAFETY INFORMATION
    8. OTC - PURPOSE
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colds And Flu Response Product Label

The following document was submitted to the FDA by the labeler of this product Beaumont Bio Med. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



HPUS active ingredients:​ Anas barbariae, hepatis et cordis extractum (50C, 100C, 200C), Arsenicum album, Baptisia tinctoria, Bryonia, Dulcamara, Echinacea, Echinacea purpurea, Eupatorium perfoliatum, Ferrum phosphoricum, Gelsemium sempervirens, Kali muriaticum, Lac defloratum, Phosphorus, Pulsatilla, Sulphur, Zincum aceticum, Zincum carbonicum, Zincum metallicum, Zincum oxydatum, Zincum picricum, Zincum valerianicum. Equal volumes of each ingredient in 10X, 30X, 100X potencies, unless otherwise noted.


Inactive Ingredient



Inactive Ingredients: Alcohol 20%, (v/v) glycerin 8% (v/v), pure water base.


Indications & Usage



Indications: For temporary relief of: •body aches & pains •nasal congestion •headaches & fevers associated with the common cold and flu.

Use according to label indications under standard homeopathic indications.


Dosage & Administration



Directions: Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve. Before initial dose, depress pump 4-5 times or until primed. Consult a physician for use in children under 12 years of age.


Warnings



Warnings: Stop use and ask a doctor if symptoms persist or worsen. If you are pregnant or breast feeding, consult a healthcare professional before use.


Otc - Keep Out Of Reach Of Children



  • Keep this and all medications out of reach of children.

Other Safety Information



Other Information: Tamper resistant for your protection. Use only if safety seal is intact. Contains 20% Ethyl Alcohol by Volume. In case of accidental overdose, contact a healthcare professional immediately.


Otc - Purpose



For temporary relief of:

  • body aches & pains
  • nasal congestion
  • headaches & fevers associated with the common cold and flu

Package Label.Principal Display Panel




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