Bm117

Bm117
SPL v1
SPL
SPL Set ID 2d905563-249b-dacf-e063-6394a90a48b3
Route
ORAL
Published
Effective Date 2015-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (30 [hp_C]) Rosa X Damascena Flowering Top Dysphania Ambrosioides Whole Potassium Cation Verbascum Thapsus Whole Hyacinthoides Non-scripta Whole Quinine Erysimum Cheiri Seed
Inactive Ingredients
Alcohol

Identifiers & Packaging

Pill Appearance
Color: white Size: 30 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-02-07

Description

How to Use Mix with half a cup of water 3-4 times per day. Ages 12 or older, 10 drops. Ages 12-2, 5 drops. Ages 2 and under, consult your Doctor.


Medication Information

Warnings and Precautions

Warnings and Storage:



Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place



*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Indications and Usage

Uses

Temporarily supports hearing function. Temporarily relieves discomfort associated with compromised hearing due to congestion and

irritation.*

Dosage and Administration

How to Use

Mix with half a cup of water 3-4 times per day. Ages 12 or older, 10 drops. Ages 12-2, 5 drops. Ages 2 and under, consult your Doctor.

Description

How to Use Mix with half a cup of water 3-4 times per day. Ages 12 or older, 10 drops. Ages 12-2, 5 drops. Ages 2 and under, consult your Doctor.

Section 50565-1

Warnings and Storage:



Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place



*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 51727-6

Inactive:

Alcohol Base to Preserve Product

Section 51945-4

Entire package label

Section 55105-1

Uses

Temporarily supports hearing function. Temporarily relieves discomfort associated with compromised hearing due to congestion and

irritation.*

Section 55106-9

Agraphis nutans D1+10C 0.10mL each (HPUS), Calc fluor D10+100C 0.10mL each (HPUS), Chenopodium D8+80C 0.10mL each (HPUS), Cherianthus cheiri D8+80C 0.10mL each (HPUS), China sulph D10+100C 0.10mL each (HPUS), Kali mur D10+100C 0.10mL each (HPUS), Rosa damascus D3+30C 0.10mL each (HPUS), Verbascum D3+30C 0.10mL each (HPUS)


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily supports hearing function. Temporarily relieves discomfort associated with compromised hearing due to congestion and

irritation.*

Dosage and Administration (34068-7)

How to Use

Mix with half a cup of water 3-4 times per day. Ages 12 or older, 10 drops. Ages 12-2, 5 drops. Ages 2 and under, consult your Doctor.

Warnings and Precautions (34071-1)

Warnings and Storage:



Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place



*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 50565-1 (50565-1)

Warnings and Storage:



Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place



*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 51727-6 (51727-6)

Inactive:

Alcohol Base to Preserve Product

Section 51945-4 (51945-4)

Entire package label

Section 55105-1 (55105-1)

Uses

Temporarily supports hearing function. Temporarily relieves discomfort associated with compromised hearing due to congestion and

irritation.*

Section 55106-9 (55106-9)

Agraphis nutans D1+10C 0.10mL each (HPUS), Calc fluor D10+100C 0.10mL each (HPUS), Chenopodium D8+80C 0.10mL each (HPUS), Cherianthus cheiri D8+80C 0.10mL each (HPUS), China sulph D10+100C 0.10mL each (HPUS), Kali mur D10+100C 0.10mL each (HPUS), Rosa damascus D3+30C 0.10mL each (HPUS), Verbascum D3+30C 0.10mL each (HPUS)


Advanced Ingredient Data


Raw Label Data

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