APIS MELLIFERA: 13 Adverse Event Reports & Safety Profile
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Drug Class: Allergens [CS] · Route: ORAL · Manufacturer: Boiron · HUMAN OTC DRUG · FDA Label: Available
First Report: 20170223 · Latest Report: 20241024
What Are the Most Common APIS MELLIFERA Side Effects?
All APIS MELLIFERA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Anaphylactic reaction | 5 | 38.5% | 0 | 0 |
Who Reports APIS MELLIFERA Side Effects? Age & Gender Data
Gender: 0.0% female, 100.0% male. Average age: 43.5 years. Most reports from: ES. View detailed demographics →
Is APIS MELLIFERA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2017 | 1 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2020 | 3 | 0 | 0 |
| 2024 | 1 | 0 | 1 |
What Is APIS MELLIFERA Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 5 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for APIS MELLIFERA
Official prescribing information from the FDA-approved drug label.
Drug Description
DESCRIPTION Ingredient name Potency Quantity Final dilution Apis mellifica 6X 30 mg 7X Argentum nitricum 6X 30 mg 7X Belladonna 4X 30 mg 5X Cantharis 6X 30 mg 7X Causticum 8X 30 mg 5X Equisetum hyemale 6X 30 mg 7X Petroselinum sativum 8X 30 mg 9X Pulsatilla 6X 30 mg 7X Sarsaparilla 6X 30 mg 7X Terebinthina 8X 30 mg 9X
FDA Approved Uses (Indications)
Uses Helps promote and maintain general female reproductive health. Product 'Uses' are based on Homeopathic Materia Medica and have not been clinically tested. These 'Uses' have not been evaluated by the Food and Drug Administration. Directions To be taken 20 minutes away from food. Place drops directly under the tongue or into ¼ oz of water. Adults and adolescents (12 years and older): Take 10 drops two to three times daily or as recommended by your healthcare practitioner. Children (under 12 years): Take under the direction of your healthcare practitioner.
Dosage & Administration
DOSAGE AND ADMINISTRATION Allow tablets to dissolve completely in the mouth, do not swallow.
- Standard Dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours. Children under 12 years: 2 tablets per day, taking 1 tablet every 6 to 8 hours.
- Acute Dosage: Adults and children 12 years and older: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours. Children under 12 years: 1 tablet every ½ to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 8 tablets in 24 hours.
DOSAGE 300 mg tablets each containing the active ingredients in the strengths listed under Description.
Contraindications
Care & contra-indications: This is a homoeopathic remedy, no contra-indications are established.
Known Adverse Reactions
To Report SUSPECTED ADVERSE REACTIONS, contact Guna Inc at (484) 223-3500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Warnings
Warnings For external use only Do not use on damaged skin, open wounds, or mucous membranes According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms). Avoid contact with the eyes Do not use if you are allergic to Apis mellifica, Gelsenium sempervirens, Gmaphalium or any of this product's inactive ingredients. Do not bandage tightly Do not use with heating pads or other heating devices. When using this product avoid contact with eyes. If pregnant, trying to get pregnant or breast-feeding , ask a health professional before use. Stop use and ask a doctor if conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Active Ingredient
ACTIVE INGREDIENTS/PURPOSE AESCULUS HIPPOCASTANUM 2X HELPS VENOUS FLOW CALENDULA OFFICINALIS 1X HELPS REDUCE SWELLING TARAXACUM OFFICINALE 1X PROMOTES URINATION APIS MELLIFICA 8X HELPS REDUCE SWELLING EQUISETUM HYEMALE 3X PROMOTES URINATION FUMARICUM ACIDUM 6X PROMOTES URINATION GRAPHITES 12X 30X 200X DETOXIFICATION JUGLANS REGIA 5X DETOXIFICATION LEVOTHYROXINUM 12X HELPS REDUCE SWELLING MAGNESIA PHOSPHORICA 12X 30X 200X DETOXIFICATION MALICUM ACIDUM 6X DETOXIFICATION MYOSOTIS ARVENSIS 4X RELIEVES SWOLLEN LYMPH NODES, INFLAMED TONSILS NATRUM OXALACETICUM 6X DETOXIFICATION NATRUM PYRUVICUM 6X DETOXIFICATION PHYTOLACCA DECANDRA 4X RELIEVES SWOLLEN LYMPH NODES, INFLAMED TONSILS PLACENTA TOTALIS SUIS 6X SUPPORTS CIRCULATION SARSAPARILLA 3X RELIEVES SWOLLEN LYMPH NODES TRICHINOYL PHOSPHATE 6X RELIEVES SWOLLEN LYMPH NODES HYDRASTIS CANADENSIS 5X RELIEVES SORE THROAT HYDROCOTYLE ASIATICA 2X RELIEVES SORE THROAT
Inactive Ingredients
Inactive ingredients beeswax, camphor, canola oil, carbomer, ceteth-20, cetyl alcohol, citrus bergamia (bergamot) oil, ethylhexylglycerin, ethylhexyl stearate, eucalyptus globulus leaf oil, glyceryl stearate, menthol, methyl salicylate, PEG-75 stearate, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium hydroxide, steareth-10, steareth-20, steareth-21, stearic acid, tocopheryl acetate, water, xanthan gum.