Label: COLD BUSTER- pelargonium sidoides syrup

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 13, 2010

If you are a consumer or patient please visit this version.

  • 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.

  • 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
  • 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.
  • PREGNANCY OR BREAST FEEDING

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

  • 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

  • QUESTIONS

    Questions?  Call 1-877-981-4328

    Find us on the Web at:

    www.BusterBrands.com

  • 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


    Cold Buster Label

  • PURPOSE

    Shortens duration and reduces severity of upper respiratory symptoms.

  • INGREDIENTS AND APPEARANCE
    COLD BUSTER 
    pelargonium sidoides syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:22955-016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PELARGONIUM SIDOIDES ROOT (UNII: H6J53HEX8E) (PELARGONIUM SIDOIDES ROOT - UNII:H6J53HEX8E) PELARGONIUM SIDOIDES ROOT24 [hp_X]  in 120 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:22955-016-20120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2010
    Labeler - SiCap Industries LLC (170665298)
    Registrant - SiCap Industries LLC (170665298)
    Establishment
    NameAddressID/FEIBusiness Operations
    SiCap Industries LLC170665298manufacture