Pediatric Earache Remedy
Aconitum napellus 6X
Belladonna 3X
Chamonilla 6X
Kali mur 3X
Plantago major 3X
Verbascum 6X
Pediatric Earache Remedy
- Manufacturer
- Vitality Works, Inc | Vitality Works, Inc.
- Effective date
- 2025-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- full-release
- Hydrated at
- 2026-06-01 02:36:09
Label at a glance#
ProductPediatric Earache Remedy
Active ingredientACONITUM NAPELLUS, ATROPA BELLADONNA, POTASSIUM CHLORIDE, PLANTAGO MAJOR, MATRICARIA RECUTITA, VERBASCUM THAPSUS
Label structure8 sections
Label contents#
Full prescribing information#
Pediatric Earache Remedy
Grapefruit Seed Extract, Olive Leaf Extract, USP Purified Water
Pediatric Earache Remedy
Keep this and all medicines out of reach of children. Before use with children under 3 years of age, or if you are pregnant or nursing, seek the advice of you health care professional. Avoid contact with eyes. If symptoms persist for more than 4 days, or if there is discharge from the ear or perforation, discontinue use and contact your health care professional. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. All the ingredients are edible but they are not intended for internal use.
Pediatric Earache Remedy
Keep this and all medicines out reach of children.
Pediatric Earache Remedy
A homeopathic combination for the temporary relief of earaches, inflammation of external and internal ear. For the temporary relief of earaches from congestion or swelling of middle ear or eustacian tubes.
Pediatric Earache Remedy
Warm up bottle by gently rolling it between your hands before use. Tilt head sideways and place 2 to 3 drops into ear. Tip of applicator should not enter ear canal. Repeat 2-3 times/day for up to 4 days, if needed, or as directed by your health care professional.
Pediatric Earache Remedy
Aconitum napellus - relieves earach, hot, painful, swollen ear.
Belladonna - relieves otitis media, throbbing deep ear pain.
Chamomilla - relieves earache, soreness, swelling, otalgia.
Kali mur - relieves chronic catarrahal conditions of middle ear.
Plantago major - relieves earache, neuralgic earache, otalgia
Verbascum - Relieves catarrhs, otalgia with sense of obstruction.
Pediatric Earache Remedy
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64616-050-01 | Pediatric Earache Remedy | 15 mL in 1 BOTTLE, DROPPER | LIQUID | 15 | 9 | |
| 64616-050-02 | Pediatric Earache Remedy | 1 in 1 CARTON | LIQUID | 1 | 9 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACONITUM NAPELLUS | ACTIVE INGREDIENT | U0NQ8555JD | 1 | |
| ATROPA BELLADONNA | ACTIVE INGREDIENT | WQZ3G9PF0H | 1 | |
| MATRICARIA RECUTITA | ACTIVE INGREDIENT | G0R4UBI2ZZ | 1 | |
| PLANTAGO MAJOR | ACTIVE INGREDIENT | W2469WNO6U | 1 | |
| POTASSIUM CHLORIDE | ACTIVE INGREDIENT | 660YQ98I10 | 1 | |
| VERBASCUM THAPSUS | ACTIVE INGREDIENT | C9TD27U172 | 1 | |
| ACONITUM NAPELLUS | ACTIVE MOIETY | U0NQ8555JD | 1 | |
| ATROPA BELLADONNA | ACTIVE MOIETY | WQZ3G9PF0H | 1 | |
| MATRICARIA RECUTITA | ACTIVE MOIETY | G0R4UBI2ZZ | 1 | |
| PLANTAGO MAJOR | ACTIVE MOIETY | W2469WNO6U | 1 | |
| POTASSIUM CATION | ACTIVE MOIETY | 295O53K152 | 1 | |
| VERBASCUM THAPSUS | ACTIVE MOIETY | C9TD27U172 | 1 | |
| CITRUS PARADISI SEED | INACTIVE INGREDIENT | 12F08874Y7 | 1 | |
| OLEA EUROPAEA LEAF | INACTIVE INGREDIENT | MJ95C3OH47 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Pediatric Earache Remedy
- Ear Drops
- GRAPEFRUIT
- OLEA EUROPAEA LEAF
- WATER
- ACONITUM NAPELLUS
- ATROPA BELLADONNA
- POTASSIUM CHLORIDE
- POTASSIUM CATION
- PLANTAGO MAJOR
- MATRICARIA RECUTITA
- VERBASCUM THAPSUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64616-050 | 64616-050-01, 64616-050-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GRAPEFRUIT | O82C39RR8C | IACT |
| OLEA EUROPAEA LEAF | MJ95C3OH47 | IACT |
| WATER | 059QF0KO0R | IACT |
| ACONITUM NAPELLUS | U0NQ8555JD | ACTIB |
| ATROPA BELLADONNA | WQZ3G9PF0H | ACTIB |
| POTASSIUM CHLORIDE | 660YQ98I10 | ACTIB |
| PLANTAGO MAJOR | W2469WNO6U | ACTIB |
| MATRICARIA RECUTITA | G0R4UBI2ZZ | ACTIB |
| VERBASCUM THAPSUS | C9TD27U172 | ACTIB |
Source Document#
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pediatric Earache Remedy | EAR DROPS | Vitality Works, Inc | 5769ce2c-d2e1-4069-92cc-e38bee668daf | 2025-12-17 | Warnings | 64616-050-02 64616-050-01 64616-050 64616005002 64616005001 462ed52e-9da2-6cc3-e063-6294a90ad318 5769ce2c-d2e1-4069-92cc-e38bee668daf |