FDA Label for Headache Buster
View Indications, Usage & Precautions
Headache 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.
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.
Otc - 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.
Otc - 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.
Otc - Stop Use
Stop use and ask doctor if symptoms persist more than two weeks or worsen or if you experience dizziness or hear palpitations.
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:
- 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
Otc - 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
Package Label.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
Otc - Purpose
Capsicum annum...........relieves migraine
Pyrethrum parthenium.......eases headache and migraine pain
Mentholum...............relieves headache symptoms
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