Indications and uses
1.1 Hevert ® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders, such as restlessness and sleep disorders, mild depressive states, and mental exhaustion.
BLACK COHOSH
- Manufacturer
- Hevert Pharmaceuticals LLC | Hevert Arzneimittel GmbH & Co. KG | Solupharm Pharmazeutische Erzeugnisse GmbH
- Effective date
- 2021-10-22
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:30:50
Label at a glance#
ProductHevert Calmvalera comp.
Active ingredientBLACK COHOSH, ANAMIRTA COCCULUS SEED, CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT, STRYCHNOS IGNATII SEED, PASSIFLORA INCARNATA FLOWERING TOP, PLATINUM, VALERIAN, ZINC VALERATE DIHYDRATE
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. Adults and children 12 years and older: 1 mL to 2 mL 1 to 3 times per 7 days. Adults and children 12 years and older: 1 mL to 2 mL up to 3 times daily. Hevert ® Cal...
Storage and handling
Hevert ® Calmvalera™ comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules NDC 54532-0036-4 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® Calmvalera™ comp. safely and effectively. See full prescribing information for Hevert® Calmvalera™ comp. Hevert® Calmvalera™ comp. solution for injection, for intravenous, intramuscular and subcutaneous administration. Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders such as restlessness and sleep disorders, mild depressive states, and mental exhaustion. (1) --------- DOSAGE AND ADMINISTRATION ---------
| -------- DOSAGE FORMS AND STRENGTHS --------
|
| FULL PRESCRIBING INFORMATION: CONTENTS* 1 Indications and Usage 2 Dosage and Administration 2.1 General Instructions 2.2 Standard Dosage 2.3 Acute Dosage 2.4 Instruction for Opening Glass Ampule 3 Dosage Forms and Strength 4 Contraindications 5 Warnings and Precautions 6 Adverse Reactions 6.1 Post-marketing Experience 7 Drug Interactions 8 Use in specific Populations 8.1 Pregnancy | 8.2 Labor and Delivery 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 10 Overdosage 11 Description 11.1 Ingredients 11.2 Pharmaceutical Form 11.3 Route of Administration 15 References 16 How Supplied / Storage and Handling 16.1 Dosage Forms and Package Sizes 16.2 Storage * Sections or subsections omitted from the full prescribing information are not listed. |
1 Indications and Usage
1.1 Hevert® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders, such as restlessness and sleep disorders, mild depressive states, and mental exhaustion.
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 and children 12 years and older:
1 mL to 2 mL 1 to 3 times per 7 days.
2.3 Acute Dosage
| Adults and children 12 years and older: 1 mL to 2 mL up to 3 times daily. Hevert® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously. |  |
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® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, 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® Calmvalera™ 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® Calmvalera™ comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Calmvalera™ 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® Calmvalera™ comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Calmvalera™ comp. is administered to a nursing woman.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Hevert® Calmvalera™ comp. has not identified differences in responses between adults and pediatric patients.
8.5 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® Calmvalera™ 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 |
| Cimicifuga racemosa | 4X | 5 % | 5.5X |
| Cocculus indicus | 4X | 5 % | 5.5X |
| Cypripedium pubescens | 4X | 5 % | 5.5X |
| Ignatia amara | 6X | 5 % | 7.5X |
| Passiflora incarnata | 4X | 5 % | 5.5X |
| Platinum metallicum | 10X | 5 % | 11.5X |
| Valeriana officinalis | 4X | 5 % | 5.5X |
| Zincum valerianicum | 8X | 5 % | 9.5X |
Inactive ingredients:
Sodium chloride 0.015 g
11.2 Pharmaceutical Form
Sterile solution for injection
11.3 Route of Administration
Parenteral: IV, IM, or SC
15 References
German Homeopathic Pharmacopeia, Clarke
16 How Supplied/Storage and Handling
16.1 Dosage Forms and Package Sizes
- Hevert® Calmvalera™ comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
- NDC 54532-0036-4
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 80303www.hevertusa.com
Made in Germany
US 529/1812
PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton
NDC 54532-0036-4
HEVERT®
CALMVALERA™
COMP.
Homeopathic
Solution for Injection
Rx only
IV IM SC
10 sterile 2.0 mL ampules
hEVERT
Products#
Every source-derived product name is available through these pages.
- Hevert Calmvalera comp.
- black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate
- BLACK COHOSH
- ANAMIRTA COCCULUS SEED
- CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT
- STRYCHNOS IGNATII SEED
- PASSIFLORA INCARNATA FLOWERING TOP
- PLATINUM
- VALERIAN
- ZINC VALERATE DIHYDRATE
- VALERIC ACID
- SODIUM CHLORIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54532-0036 | 54532-0036-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BLACK COHOSH | K73E24S6X9 | ACTIB |
| ANAMIRTA COCCULUS SEED | 810258W28U | ACTIB |
| CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT | 21Y9GZ1LZA | ACTIB |
| STRYCHNOS IGNATII SEED | 1NM3M2487K | ACTIB |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| PLATINUM | 49DFR088MY | ACTIB |
| VALERIAN | JWF5YAW3QW | ACTIB |
| ZINC VALERATE DIHYDRATE | MN0RX54EQA | 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 |
|---|---|---|---|---|---|---|
| db8a9bb1-6223-4ba0-bf2a-7fbf5df642bf | d8b13f26-ed02-4c88-b661-b028d2273b6f | 2021-10-22 | Warnings, Adverse reactions | db8a9bb1-6223-4ba0-bf2a-7fbf5df642bf d8b13f26-ed02-4c88-b661-b028d2273b6f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.