Label: EARACHE RELIEF- apis mellifera, arnica montana, atropa belladonna, tribasic calcium phosphate, echinacea, unspecified, calcium sulfide, mercurius solubilis tablet, orally disintegrating
- NDC Code(s): 17312-025-14
- Packager: TRP Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 10, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Apis mellifica HPUS - 6x, 12x, 18x
Arnica montana HPUS - 6x, 12x, 18x
Belladonna HPUS - 6x, 12x, 18x
Calcarea phosphorica HPUS - 6x, 12x, 18x
Echinacea HPUS - 3x
Hepar sulphuris calcareum HPUS - 6x, 12x, 18x
Mercurius solubilis HPUS - 6x, 12x, 18x
HPUS indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
-
PURPOSE
Apis mellifica HPUS - Discomfort, Redness of external ear
Arnica montana - Bruised sensation in external ears
Belladonna HPUS - Fullness, Congestion
Calcarea phosphorica HPUS - Itching, Coldness, Irritability
Echinacea HPUS - Immune support
Hepar sulphuris calcareum HPUS - Sensitivity to water, wind, cold and touch
Mercurius solubilis - Swimmer’s ear irritation
- Uses
-
Warnings
USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.
This product is intended to complement, not replace, standard medical treatment.
- Initial worsening of symptoms may occur.
- A physician should always be consulted to rule out serious causes.
- In case of overdose, get medical help or contact a Poison Control Center right away.
- PREGNANCY OR BREAST FEEDING
- Keep out of reach of children
-
Directions
- Suitable for adults and children 12 years and above.
- Dissolve entire tablet under tongue.
- Do not chew or swallow whole.
- Take 1 tablet 3 times a day or as directed by a physician.
- Use up to 6 times a day as needed.
- Take at least 10 minutes before or at least 10 minutes after eating or drinking.
- Children under the age of 12: consult a physician before use.
- Homeopathic remedies may not be effective for everyone.
-
Other information
- There are no known contraindications.
- Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.
- Store in a cool dark location.
- EarAche Relief Fast Dissolving Tablets are homeopathic dilutions: see www.thereliefproducts.com for details.
- Inactive Ingredients
- Do not use if tamper evident seal is torn, broken or missing.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EARACHE RELIEF
apis mellifera, arnica montana, atropa belladonna, tribasic calcium phosphate, echinacea, unspecified, calcium sulfide, mercurius solubilis tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-025 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 6 [hp_X] ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 6 [hp_X] TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 6 [hp_X] ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 3 [hp_X] CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 6 [hp_X] MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 6 [hp_X] Inactive Ingredients Ingredient Name Strength MANNITOL (UNII: 3OWL53L36A) SORBITOL (UNII: 506T60A25R) CROSPOVIDONE (UNII: 68401960MK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) COPOVIDONE (UNII: D9C330MD8B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape DIAMOND Size 13mm Flavor Imprint Code TRP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-025-14 1 in 1 PACKAGE 04/28/2015 1 70 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/05/2013 Labeler - TRP Company (105185719)
