Headache Buster
FDA Label NDC 22955-013

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 Headache Buster (NDC 22955-013). 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 warnings, otc - ask doctor, otc - when using, 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

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

    Headache Buster Label (Headachebusterlabel)

    Headache Buster Label (Headachebusterlabel)

Otc - Purpose

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

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

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

* Please review the disclaimer below.