HEADACHE BUSTER- capsicum annuum, pyrethrum parthenium, mentholum spray

Headache Buster by

Drug Labeling and Warnings

Headache Buster by is a Homeopathic medication manufactured, distributed, or labeled by SiCap Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

For nasal use only.  Upon initial use, you will experience a powerful sensation which lasts a few seconds.  This sensation is inherent to the process that allows the capsaicin to work.  Temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may result.

ASK DOCTOR

Ask a doctor before use if you have:

• ever had any medical procedures relating to your nose or sinuses, or you're susceptible to nose bleeds
• allergies to any of the ingredients.

WHEN USING

When using this product:

• Avoid contact with the eyes, In case of accidental contact with eyes, flush with water (and immediately seek professional help).
• The use of this container by more than one person may spread infection.

STOP USE

Stop use and ask doctor if symptoms persist more than two weeks or worsen or if you experience dizziness or hear palpitations.

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:

• Adults and children 12 years of age and older:  use as needed at the first sign of symptoms.  Pump 1-3 times in each nostril.
• Children under 12 years of age:  Consult a doctor before use.

To use pump:  Shake well.  Remove cap and safety clip.  Hold with thumb at bottom of bottle and place nozzle between fingers.  Before using the first time, prime pump by depressing several times.  Insert nozzle into nostril and firmly depress rim.  Sniff deeply.

STORAGE AND HANDLING

• Store at room temperature 15-29 degrees C (59-84 degrees F
• Retain carton for future reference on full labeling

INACTIVE INGREDIENT

Ascorbic Acid (Crystallized Vitamin C), Eucalyptol, Purified Water, Rosemary Extract, Sea Salt, Vegetable Glycerin

QUESTIONS

Questions?  Call 1-877-981-4328

Find us on the web at: www.BusterBrands.com

INDICATIONS & USAGE

For temporary relief of:

• Migraine headaches
• Cluster headaches
  

PRINCIPAL DISPLAY PANEL

100%  Natural Chemical Free

Non-drowsy

No Known Drug Interactions

Non-habit Forming

Relieves:

• Migraine Headaches
• Cluster Headaches
  

made with Capsaicin Pepper, Feverfew and Peppermint

Made in the USA
Not tested on Animals

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

PURPOSE

Capsicum annum...........relieves migraine

Pyrethrum parthenium.......eases headache and migraine pain

Mentholum...............relieves headache symptoms

INGREDIENTS AND APPEARANCE

HEADACHE BUSTER 
capsicum annuum, pyrethrum parthenium, mentholum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 22955-013
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RED PEPPER (UNII: 6M47G7C4SY) (RED PEPPER - UNII:6M47G7C4SY)	RED PEPPER	4 [hp_X]  in 20 mL
TANACETUM PARTHENIUM (UNII: 6GE7Z0761K) (TANACETUM PARTHENIUM - UNII:6GE7Z0761K)	TANACETUM PARTHENIUM	3 [hp_X]  in 20 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 [hp_X]  in 20 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 22955-013-20	20 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		12/31/2008

Labeler - SiCap Industries LLC (170665298)

Registrant - SiCap Industries LLC (170665298)

Establishment
Name	Address	ID/FEI	Business Operations
SiCap Industries LLC		170665298	manufacture