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  5. Label Information: Cold And Flu Relief

FDA Label for Cold And Flu Relief

View Indications, Usage & Precautions

Table of Contents

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

Cold And Flu Relief Product Label

The following document was submitted to the FDA by the labeler of this product Eight And Company L.l.c. 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



Active Ingredients: Allium cepa 30C, Antimonium tartaricum 200C, Arnica montana 3X, Baptisia tinctoria 3X, Eupatorium perfoliatum 200C, Gelsemium sempervirens 200C, Kali bichromicum 200C, Lachesis mutus 200C, Mercurius iodatus ruber 200C, Sticta pulmonaria 200C, Sulphur iodatum 200C, Urtica urens 200C.


Warnings



Warnings: ​If symptoms persist or worsen, seek advice of physician. If pregnant or breast-feeding, ask a health care professional before using. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Indications & Usage



Temporarily relieves the common symptoms of cold and flu, including:

  • sinus congestion
  • achiness
  • chills
  • headache and fever

Dosage & Administration



  • Adults and children over 12: 2 sprays under the tongue each 30 minutes as needed for symptom relief the first day, 2 sprays 3 times a day thereafter.
  • Ages 2 to 12: 1 spray under the tongue each 30 minutes as needed for the first day, 1 spray 3 times a day thereafter.
  • Under age 2: consult a health care professional.

Other Safety Information



Other Information: Do not use if the transparent seal around spray bottle is broken or missing.


Inactive Ingredient



Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v, purified water.


Otc - Purpose



Temporarily relieves the common symptoms of cold and flu, including:

° sinus congestion

° achiness

° chills

° headache and fever

° natural

° gluten free

° no artifical flavors or colors

° vegetarian

° no known negative side effects

° no known negative drug interactions


* Please review the disclaimer below.