Headache
- Manufacturer
- Apotheca Company
- Effective date
- 2022-04-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:04:29
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
CONTENTS: Belladonna 30X, Bryonia 30X, Gelsemium Sempervirens 30X, Glonoinum 30X, Melilotus Officinalis 30X, Natrum Muriaticum 30X, Nitricum Acidum 30X, Nux Vomica 30X, Silicea 30X, Spigelia Anthelmia 30X.
OTC - PURPOSE SECTION
INDICATIONS: For temporary relief of symptoms due to tension and pressure of the head, headache.
WARNINGS SECTION
WARNINGS: If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in a cool, dry place.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
SUGGESTED USE: Adults and children 5 to 10 drops orally, 3 times daily or as directed by a health cars professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.
INDICATIONS & USAGE SECTION
INDICATIONS: For temporary relief of symptoms due to tension and pressure of the head, headache.
INACTIVE INGREDIENT SECTION
OTHER INGREDIENTS: Demineralized Water, 20% Ethanol
OTC - QUESTIONS SECTION
Dist. By:
Energique, Inc.
201 Apple Blvd.
Woodbine, IA 51579
800-869-8078
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ENERGIQUE
HEADACHE HP
HOMEOPATHIC REMEDY
1 FL OZ (30 ML)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0305-1 | 2022-04-04 | C162847 | 48780-1 | 9d75b9d1-0cb1-f424-e053-dadaa90a57ce | Headache HP |
| 57520-0305-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0cb1-f424-e053-dadaa90a57ce | Headache HP |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| BRYONIA ALBA ROOT | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| GELSEMIUM SEMPERVIRENS ROOT | ACTIVE INGREDIENT | 639KR60Q1Q | 1 | |
| MELILOTUS OFFICINALIS POLLEN | ACTIVE INGREDIENT | UVC3Z60VTX | 1 | |
| NITRIC ACID | ACTIVE INGREDIENT | 411VRN1TV4 | 1 | |
| NITROGLYCERIN | ACTIVE INGREDIENT | G59M7S0WS3 | 1 | |
| SILICON DIOXIDE | ACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM CHLORIDE | ACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SPIGELIA | ACTIVE INGREDIENT | 467D26HS0B | 1 | |
| STRYCHNOS NUX-VOMICA SEED | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| BRYONIA ALBA ROOT | ACTIVE MOIETY | T7J046YI2B | 1 | |
| GELSEMIUM SEMPERVIRENS ROOT | ACTIVE MOIETY | 639KR60Q1Q | 1 | |
| MELILOTUS OFFICINALIS POLLEN | ACTIVE MOIETY | UVC3Z60VTX | 1 | |
| NITRIC ACID | ACTIVE MOIETY | 411VRN1TV4 | 1 | |
| NITROGLYCERIN | ACTIVE MOIETY | G59M7S0WS3 | 1 | |
| SILICON DIOXIDE | ACTIVE MOIETY | ETJ7Z6XBU4 | 1 | |
| SODIUM CATION | ACTIVE MOIETY | LYR4M0NH37 | 1 | |
| SPIGELIA | ACTIVE MOIETY | 467D26HS0B | 1 | |
| STRYCHNOS NUX-VOMICA SEED | ACTIVE MOIETY | 269XH13919 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Headache HP
- Belladonna, Bryonia, Gelsemium sempervirens, Glonionum, Melilotus officinalis, Natrum muriaticum, Nitricum acidum, Nux vomica, Silicea Spigelia anthelmia
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- GELSEMIUM SEMPERVIRENS ROOT
- NITROGLYCERIN
- SODIUM CHLORIDE
- SODIUM CATION
- NITRIC ACID
- STRYCHNOS NUX-VOMICA SEED
- SILICON DIOXIDE
- MELILOTUS OFFICINALIS POLLEN
- WATER
- ALCOHOL
- SPIGELIA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0305 | 57520-0305-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| BRYONIA ALBA ROOT | T7J046YI2B | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| NITROGLYCERIN | G59M7S0WS3 | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| NITRIC ACID | 411VRN1TV4 | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | ACTIB |
| MELILOTUS OFFICINALIS POLLEN | UVC3Z60VTX | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| SPIGELIA | 467D26HS0B | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f98d055a-1902-4137-ba2b-2300a0385996 | 42076697-cbba-4aca-a405-72a9f8badd20 | 2022-04-01 | Warnings | f98d055a-1902-4137-ba2b-2300a0385996 42076697-cbba-4aca-a405-72a9f8badd20 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
