FDA Label for Cold Buster

View Indications, Usage & Precautions

Cold Buster Product Label

The following document was submitted to the FDA by the labeler of this product Sicap Industries Llc. 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.

Indications & Usage



  • Shortens duration and reduces severity of symptoms associated with common colds and throat/sinus/bronchial infections:
  • Chills/Fevers
  • Headache
  • Sore Throat
  • Sneezing/Runny Nose
  • Congestion
  • Hoarseness
  • Stuffy Nose
  • Cough
  • Minor Aches/Pains

Warnings And Precautions



Warnings

Sore Throat Warning:  if sore throat persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea or vomitting, consult a doctor promptly.


Otc - Ask Doctor



Ask a doctor before use if you have:

  • a cough that lasts, is chronic such as occurs with smoking, asthma, or emphysema, or is accompanied by excessive phlegm (mucus).
  • allergies to any of the ingredients

Otc - Stop Use



Stop use and ask a doctor if:

  • New symptoms occur, symptoms get worse or last more than 7 days
  • Fever worsens or lasts more than 3 days
  • Cough lasts more than 7 days or occurs with rash or persistent headache
  • These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health care professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions:

For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Age                                   Dose

Adults and Children         take 1 teaspoon (5ml)
12 years of age            3 times daily
and older:


Children 6 to 11:           take 1 teaspoon (5ml)
                                  2 times daily


Children under 6:          Consult a doctor before use.

Storage And Handling



  • Store at room temperature 20-25 degrees C (68 to 77 degrees F) in a dry place out of direct sunlight
  • Plastic dosage cup provided

Inactive Ingredient



Ascorbic Acid (Crystallized Vitamin C), Capsicum Extract, Honey, Natural Lemon Flavor, Potassium Sorbate, Purified Water, Vegetable Glycerin


Otc - Questions



Questions?  Call 1-877-981-4328

Find us on the Web at:

www.BusterBrands.com


Package Label.Principal Display Panel



Recover Faster

  • Shortens duration and reduces severity of cold symptoms
  • Loosens mucous
  • Boosts the immune system
  • Soothes and warms on contact
  • Recover Faster:
    Unlike many remedies that simply mask symptoms, Cold Buster speeds recovery.  The active ingredient in Cold Buster has been clinically shown to significantly reduce duration and severity of cold symptoms.

    Powerful 3-way Effect:
    • Attacks the cause of illness
    • Speeds up the movement of mucus out of the respiratory tract
    • Boosts the immune system
    • Clinical Tested Safety:
      The active ingredient in Cold Buster is one of the most researched plant-based medicines available.

      Warming Honey Lemon Syrup:
      Provides an immediate soothing spread of warmth from your throat down into your chest.

      Non-Drowsy, Zinc-Free Formula:
      Can use any time of day with no unpleasant zinc aftertaste.

      Made in the USA

      Not tested on animals

      Distributed by:
      SiCap LLC, Albany,
      New York 12205,
      a wholly owned subsidiary of Dynova Laboratories, Inc.
      www.BusterBrands.com




Otc - Purpose



Shortens duration and reduces severity of upper respiratory symptoms.


* Please review the disclaimer below.