Label at a glance#

ProductCold Buster

Active ingredientPELARGONIUM SIDOIDES ROOT

Label structure12 sections

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

Contacts and useful links#

PhoneLabel contact1-877-981-4328

Websitewww.busterbrands.com

www.BusterBrands.com

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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 SECTION

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 SECTION

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 SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

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

OTC - QUESTIONS SECTION

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 SECTION

Shortens duration and reduces severity of upper respiratory symptoms.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
22955-016-20	2019-10-21	C162847	48780-1	956f9ecf-d0d7-621f-e053-dbdaa90a74ad	6d46d949-d3e9-4514-b4f4-dfcdfdf91a38

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
22955-016-20	Cold Buster	120 mL in 1 BOTTLE	SYRUP	120		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
22955-016	COLD BUSTER (PELARGONIUM SIDOIDES) SYRUP [SICAP INDUSTRIES LLC]	1	Legacy NDC, 1 package rows	20100701_6d46d949-d3e9-4514-b4f4-dfcdfdf91a38.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
PELARGONIUM SIDOIDES ROOT	ACTIVE INGREDIENT	H6J53HEX8E	1
PELARGONIUM SIDOIDES ROOT	ACTIVE MOIETY	H6J53HEX8E	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Cold Buster
Pelargonium sidoides
PELARGONIUM SIDOIDES ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
22955-016	22955-016-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PELARGONIUM SIDOIDES ROOT	H6J53HEX8E	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
40c0a800-3c47-4b8c-9ad1-6e4dbca51a1b			6d46d949-d3e9-4514-b4f4-dfcdfdf91a38	2010-04-13	Warnings	Exact identifier spl id: 40c0a800-3c47-4b8c-9ad1-6e4dbca51a1b spl set id: 6d46d949-d3e9-4514-b4f4-dfcdfdf91a38

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.