FDA.reportPublic FDA data

Headache Buster

Manufacturer
SiCap Industries LLC
Effective date
2010-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:02:16

Label at a glance#

ProductHeadache Buster
Active ingredientRED PEPPER, TANACETUM PARTHENIUM, MENTHOL
Label structure13 sections

Storage and handling

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

Label contents#

Full prescribing information#

WARNINGS SECTION

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 SECTION

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 SECTION

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 SECTION

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 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:

  • 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 SECTION

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

INACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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 LabelHeadache Buster Label

OTC - PURPOSE SECTION

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

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
22955-013-202019-10-21C16284748780-1956f9ecf-d026-621f-e053-dbdaa90a74ad9d2277cc-62f8-4d09-9e37-a610cd62966d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22955-013-20Headache Buster20 mL in 1 BOTTLE, SPRAYSPRAY201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22955-013HEADACHE BUSTER (CAPSICUM ANNUUM, PYRETHRUM PARTHENIUM, MENTHOLUM) SPRAY [SICAP INDUSTRIES LLC]1Legacy NDC, 1 package rows20100420_9d2277cc-62f8-4d09-9e37-a610cd62966d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
RED PEPPERACTIVE INGREDIENT6M47G7C4SY1
TANACETUM PARTHENIUMACTIVE INGREDIENT6GE7Z0761K1
MENTHOLACTIVE MOIETYL7T10EIP3A1
RED PEPPERACTIVE MOIETY6M47G7C4SY1
TANACETUM PARTHENIUMACTIVE MOIETY6GE7Z0761K1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
22955-01322955-013-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
RED PEPPER6M47G7C4SYACTIB
TANACETUM PARTHENIUM6GE7Z0761KACTIB
MENTHOLL7T10EIP3AACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7be3b9f3-22c4-460d-82ec-cac81980a20f9d2277cc-62f8-4d09-9e37-a610cd62966d2010-04-19WarningsExact identifier
spl id: 7be3b9f3-22c4-460d-82ec-cac81980a20f
spl set id: 9d2277cc-62f8-4d09-9e37-a610cd62966d

Reported adverse events (FAERS/openFDA)#

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