Headache
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-12-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:35:37
Label at a glance#
ProductHeadache
Active ingredientMICRURUS CORALLINUS VENOM, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CENTAUREA BENEDICTA, BLACK COHOSH, ARABICA COFFEE BEAN, CONVALLARIA MAJALIS, CROTALUS HORRIDUS HORRIDUS VENOM, DIGITALIS, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, STRYCHNOS IGNATII SEED, LACHESIS MUTA VENOM, MERCURY, NAJA NAJA VENOM, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, CLAVICEPS PURPUREA SCLEROTIUM, VIPERA BERUS VENOM, APIS MELLIFERA, HYPERICUM PERFORATUM, THUJA OCCIDENTALIS LEAFY TWIG
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush/dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Apis mel. 6x, Hypericum 6x, Thuja occ 6x, Arsenicum alb 15x, Belladonna 15x, Bryonia 15x, Carduus ben 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus hor 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc viv 15x, Naja 15x, Nux vom 15x, Phos. 15x, Rhus tox 15x, Sanguinaria 15x, Secale 15x, Vipera 16x, Elaps 30x.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
QUESTIONS SECTION
newtonlabs.net - Questions? 800.448.7256
Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a doctor before use.
WARNINGS SECTION
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  www.newtonlabs.net/Headache/productinfo/N013/ | N013-P01.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2598-1 | Headache | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 1 |
Products#
Every source-derived product name is available through these pages.
- Headache
- Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ..
- SUCROSE
- MICRURUS CORALLINUS VENOM
- ARSENIC TRIOXIDE
- ARSENIC CATION (3+)
- ATROPA BELLADONNA
- BRYONIA ALBA ROOT
- CENTAUREA BENEDICTA
- BLACK COHOSH
- ARABICA COFFEE BEAN
- CONVALLARIA MAJALIS
- CROTALUS HORRIDUS HORRIDUS VENOM
- DIGITALIS
- GELSEMIUM SEMPERVIRENS ROOT
- NITROGLYCERIN
- STRYCHNOS IGNATII SEED
- LACHESIS MUTA VENOM
- MERCURY
- NAJA NAJA VENOM
- STRYCHNOS NUX-VOMICA SEED
- PHOSPHORUS
- TOXICODENDRON PUBESCENS LEAF
- SANGUINARIA CANADENSIS ROOT
- CLAVICEPS PURPUREA SCLEROTIUM
- VIPERA BERUS VENOM
- APIS MELLIFERA
- HYPERICUM PERFORATUM
- THUJA OCCIDENTALIS LEAFY TWIG
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-2598 | 55714-2598-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Headache | ELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC.. | Newton Laboratories, Inc. | 44ffb50a-7bfe-428b-e063-6394a90a9dcf | 2025-12-02 | Warnings | 55714-2598-1 55714-2598 55714259801 44ffb50a-7bff-428b-e063-6394a90a9dcf 44ffb50a-7bfe-428b-e063-6394a90a9dcf |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.