Cold Buster
FDA Label NDC 22955-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sicap Industries Llc for the product Cold Buster (NDC 22955-016). 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 indications & usage, warnings and precautions, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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


      Cold Buster Label (Coldbusterlabel)

      Cold Buster Label (Coldbusterlabel)


Otc - Purpose

Shortens duration and reduces severity of upper respiratory symptoms.

* Please review the disclaimer below.