SPL v2
SPL
SPL Set ID b7a1fb57-3f47-7cf2-e053-2a95a90a312c
Route
ORAL
Published
Effective Date 2020-01-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (8 [hp_X]) Bryonia Alba Root Causticum Cinchona Officinalis Bark Solanum Dulcamara Top Goldenseal Bromide Ion Sulfur
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: HLB Shape: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-01-01

Description

Active Ingredients HPUS: Arnica montana (Leopard's bane)            8[hp-X] Bryonia (White bryony)                          8 [hp-X] Causticum (Hahnmann's causticum)        8 [hp-X] Cinchona officinalis (Peruvian bark)        8 [hp-X] Dulcamara (Bittersweet)                          8 [hp-X] Hydrastis canadensis (Golden seal)          8 [hp-X] Kali bromatum (Potassium bromide)       8 [hp-X] Sulphur (Sublimed sulfur)                       8 [hp-X]


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if symptoms worsen or last for more than 7 days.

If you are pregnant or breastfeeding, ask a health professional before use.

Indications and Usage

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated

  • with tinnitus
  • Rigging and buzzing in the ears
  • Ear pain & pressure
  • Headache
Dosage and Administration

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional

Age…………………………………………………………........ Dose

Adults and Children 12 years of age and older………...... 2 tablets

Children 2 to 11 years of age…...……………………............ 1 tablet

Children under 2 years of age……………………................. Ask a doctor

Description

Active Ingredients HPUS: Arnica montana (Leopard's bane)            8[hp-X] Bryonia (White bryony)                          8 [hp-X] Causticum (Hahnmann's causticum)        8 [hp-X] Cinchona officinalis (Peruvian bark)        8 [hp-X] Dulcamara (Bittersweet)                          8 [hp-X] Hydrastis canadensis (Golden seal)          8 [hp-X] Kali bromatum (Potassium bromide)       8 [hp-X] Sulphur (Sublimed sulfur)                       8 [hp-X]

Section 44425-7

Other information

  • Store at room temperature.
  • Do not use if seal is broken or missing.
Section 50565-1

Keep out of reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

Section 51727-6

Inactive ingredients

Lactose, Magnesium Stearate.

Section 55105-1

Purpose

Homeopathic remedy helps relieve symptoms of tinnitus:

  • Rigging and buzzing in the ears
  • Ear pain & pressure
  • Headache

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 55106-9

Active Ingredients HPUS:

Arnica montana (Leopard's bane)            8[hp-X]

Bryonia (White bryony)                          8 [hp-X]

Causticum (Hahnmann's causticum)        8 [hp-X]

Cinchona officinalis (Peruvian bark)        8 [hp-X]

Dulcamara (Bittersweet)                          8 [hp-X]

Hydrastis canadensis (Golden seal)          8 [hp-X]

Kali bromatum (Potassium bromide)       8 [hp-X]

Sulphur (Sublimed sulfur)                       8 [hp-X]

Product Label


Structured Label Content

Indications and Usage (34067-9)

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated

  • with tinnitus
  • Rigging and buzzing in the ears
  • Ear pain & pressure
  • Headache
Dosage and Administration (34068-7)

Directions

Chew tablets and let dissolve in mouth.

Do not use more than directed.

Do not take with food.

Repeat 3 times daily and reduce intake with improvement or as directed by a health professional

Age…………………………………………………………........ Dose

Adults and Children 12 years of age and older………...... 2 tablets

Children 2 to 11 years of age…...……………………............ 1 tablet

Children under 2 years of age……………………................. Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if symptoms worsen or last for more than 7 days.

If you are pregnant or breastfeeding, ask a health professional before use.

Section 44425-7 (44425-7)

Other information

  • Store at room temperature.
  • Do not use if seal is broken or missing.
Section 50565-1 (50565-1)

Keep out of reach of children.

In case of accidental overdose, contact a medical professional or poison control center immediately.

Section 51727-6 (51727-6)

Inactive ingredients

Lactose, Magnesium Stearate.

Section 55105-1 (55105-1)

Purpose

Homeopathic remedy helps relieve symptoms of tinnitus:

  • Rigging and buzzing in the ears
  • Ear pain & pressure
  • Headache

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Arnica montana (Leopard's bane)            8[hp-X]

Bryonia (White bryony)                          8 [hp-X]

Causticum (Hahnmann's causticum)        8 [hp-X]

Cinchona officinalis (Peruvian bark)        8 [hp-X]

Dulcamara (Bittersweet)                          8 [hp-X]

Hydrastis canadensis (Golden seal)          8 [hp-X]

Kali bromatum (Potassium bromide)       8 [hp-X]

Sulphur (Sublimed sulfur)                       8 [hp-X]

Product Label (Product label)


Advanced Ingredient Data


Raw Label Data

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