Indications and uses
1.1 Hevert ® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain.
Hevert Gelsemium comp
- Manufacturer
- Hevert Pharmaceuticals LLC | Hevert Arzneimittel GmbH & Co. KG | Solupharm Pharmazeutische Erzeugnisse GmbH
- Effective date
- 2021-10-21
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:30:24
Label at a glance#
ProductHevert Gelsemium comp
Active ingredientACONITUM NAPELLUS WHOLE, ANAMIRTA COCCULUS SEED, CITRULLUS COLOCYNTHIS FRUIT, GELSEMIUM SEMPERVIRENS ROOT, LACHESIS MUTA VENOM, DAPHNE MEZEREUM BARK, STRYCHNOS NUX-VOMICA SEED, LEAD ACETATE ANHYDROUS, TOXICODENDRON PUBESCENS SHOOT
Label structure15 sections
Dosage and administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Draw up required dose into syringe. Discard any unused ampule contents. Do not reuse ampule. 1 mL to 2 mL 1 to 3 times per 7 days. Adults: 1 mL to 2 mL up to 3 times daily. Hevert ® Gelsemium comp. may be administered intramuscularly, subcutaneously, or int...
Storage and handling
Hevert ® Gelsemium comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules NDC 54532-0027-4 Store at 68 to 77 °F. Protect from light. Keep out of reach of children
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchWebsitewww.hevertusa.com
www.hevertusa.com
www.hevertusa.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Hevert® Gelsemium comp. safely and effectively. See full prescribing information for Hevert® Gelsemium comp. Hevert® Gelsemium comp. solution for injection, for intramuscular, subcutaneous, and intracutaneous administration. Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain. (1) --------- DOSAGE AND ADMINISTRATION ---------
Hevert® Gelsemium comp. may be administered intramuscularly, subcutaneously, or intracutaneously. (2) | -------- DOSAGE FORMS AND STRENGTHS --------
---------------- CONTRAINDICATIONS ----------------
--------- WARNINGS AND PRECAUTIONS ---------
---------------- ADVERSE REACTIONS ----------------
---------------- DRUG INTERACTIONS ----------------
---------- USE IN SPECIFIC POPULATIONS ----------
|
1 Indications and Usage
1.1 Hevert® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain.
2 Dosage and Administration
2.1 General Instructions
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
- Draw up required dose into syringe.
- Discard any unused ampule contents. Do not reuse ampule.
2.2 Standard Dosage
Adults
1 mL to 2 mL 1 to 3 times per 7 days.
2.3 Acute Dosage
SPL UNCLASSIFIED SECTION
| Adults: 1 mL to 2 mL up to 3 times daily. Hevert® Gelsemium comp. may be administered intramuscularly, subcutaneously, or intracutaneously. |  |
2.4 Instruction for Opening Glass Ampule
- Cutting open the glass ampule is not necessary. Hold the ampule head up at an angle, and tap/shake down the solution contained in the ampule head. Then break off the ampule head by applying pressure away from the color dot. Discard unused solution.
3 Dosage Forms and Strengths
One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description.
4 Contraindications
Hevert® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, or to any of its ingredients.
5 Warnings and Precautions
Keep out of reach of children.
6 Adverse Reactions
6.1 Post-marketing Experience
No adverse reactions have been reported with a causal relationship to Hevert® Gelsemium comp.
7 Drug Interactions
No interactions have been reported, and none are expected due to the homeopathic dilutions.
8 Use in specific Populations
8.1 Pregnancy
8.1.1 Teratogenic effects
Pregnancy Category C
Animal reproduction studies have not been performed with Hevert® Gelsemium comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Gelsemium comp. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
8.1.2 Non-teratogenic effects
No non-teratogenic effects are known.
8.2 Labor and Delivery
No recognized use in labor or delivery.
8.3 Nursing Mothers
It is not known whether Hevert® Gelsemium comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Gelsemium comp. is administered to a nursing woman.
8.4 Geriatric Use
Safety and effectiveness in elderly patients (≥65 years of age) have not been established. However, traditional homeopathic use of the ingredients in Hevert® Gelsemium comp. has not identified differences in responses between adults and geriatric patients.
10 Overdosage
No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.
11 Description
11.1 Ingredients
Each 2 mL solution for injection ampule contains:
| Active Ingredients: | |||
|---|---|---|---|
| Ingredient name | Potency | Quantity | Final dilution |
| Aconitum napellus | 4X | 5 % | 5.5X |
| Cocculus indicus | 4X | 5 % | 5.5X |
| Colocynthis | 4X | 5 % | 5.5X |
| Gelsemium sempervirens | 4X | 5 % | 5.5X |
| Lachesis mutus | 12X | 5 % | 13.5X |
| Mezereum | 6X | 5 % | 7.5X |
| Nux vomica | 6X | 5 % | 7.5X |
| Plumbum aceticum | 6X | 5 % | 7.5X |
| Rhus toxicodendron | 6X | 5 % | 7.5X |
Inactive ingredients:
Sodium chloride 0.014 g
11.2 Pharmaceutical Form
Sterile solution for injection
11.3 Route of Administration
Parenteral: IM, SC or IC
15 References
German Homeopathic Pharmacopeia, Clarke
16 How Supplied/Storage and Handling
16.1 Dosage Forms and Package Sizes
- Hevert® Gelsemium comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
- NDC 54532-0027-4
16.2 Storage
- Store at 68 to 77 °F. Protect from light.
- Keep out of reach of children
SPL UNCLASSIFIED SECTION
Distributed by:
Hevert Pharmaceuticals, LLC, Boulder, CO 80303 www.hevertusa.com
Made in Germany
US 530/1812
PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton
NDC 54532-0027-4
HEVERT®
GELSEMIUM
COMP.
Homeopathic
Solution for Injection
Rx only
IM SC IC
10 sterile 2.0 mL ampules
hEVERT
Products#
Every source-derived product name is available through these pages.
- Hevert Gelsemium comp
- aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot
- ACONITUM NAPELLUS WHOLE
- ANAMIRTA COCCULUS SEED
- CITRULLUS COLOCYNTHIS FRUIT
- GELSEMIUM SEMPERVIRENS ROOT
- LACHESIS MUTA VENOM
- DAPHNE MEZEREUM BARK
- STRYCHNOS NUX-VOMICA SEED
- LEAD ACETATE ANHYDROUS
- LEAD Cation PB4+
- TOXICODENDRON PUBESCENS SHOOT
- SODIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54532-0027 | 54532-0027-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACONITUM NAPELLUS WHOLE | U0NQ8555JD | ACTIB |
| ANAMIRTA COCCULUS SEED | 810258W28U | ACTIB |
| CITRULLUS COLOCYNTHIS FRUIT | 0E49E3V9U6 | ACTIB |
| GELSEMIUM SEMPERVIRENS ROOT | 639KR60Q1Q | ACTIB |
| LACHESIS MUTA VENOM | VSW71SS07I | ACTIB |
| DAPHNE MEZEREUM BARK | X2N6E405GV | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| LEAD ACETATE ANHYDROUS | KL498O6790 | ACTIB |
| TOXICODENDRON PUBESCENS SHOOT | 46PYZ1F82M | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
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 |
|---|---|---|---|---|---|---|
| ddd6316e-3775-4858-9e7f-fbb4b0a6f261 | 5856840b-9012-4613-8de4-3ad0f4ed110e | 2021-10-21 | Warnings, Adverse reactions | ddd6316e-3775-4858-9e7f-fbb4b0a6f261 5856840b-9012-4613-8de4-3ad0f4ed110e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.