Com-pare2 Black Elderberry Cold + Flu Relief Tm

Com-pare2 Black Elderberry Cold + Flu Relief Tm
SPL v3
SPL
SPL Set ID a6231fe1-1f0f-04c8-e053-2a95a90a6ee7
Route
ORAL
Published
Effective Date 2020-05-20
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bryonia Alba Root (6 [hp_X]) Gelsemium Sempervirens Root (3 [hp_X]) Sambucus Nigra Flowering Top (12 [hp_X]) Sulfur (2 [hp_X]) Zinc Cation
Inactive Ingredients
Black Carrot Anthocyanins Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Sucrose European Elderberry Juice

Identifiers & Packaging

Pill Appearance
Shape: round Color: purple Size: 10 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-05-20

Description

​Active Ingredients (In each tablet): Bryonia 6X HPUS, Gelsemium sempervirens 6X, 12X, 30X HPUS, Sambucus nigra 3X, 6X HPUS, Sulphur 12X HPUS, Zincum gluconicum 2X, 6X HPUS * ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

​Warnings

​A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 4 years of age unless directed by 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.

If pregnant or breast feeding​, ask a health professional before using.

Indications and Usage

​Uses*

According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sore throat, coughing, sneezing, and chills and fever, after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage and Administration

​Directions

• Suitable for adults and children ages 4 and over. Children under the age of 4: Consult a physician before use. • For best results, take at the start of the symptoms for cold or flu and continue to take for another 48 hours after the symptoms end. • Dissolve entire tablet under tongue. • Do not chew or swallow whole. • Take 1 tablet every three hours. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

Description

​Active Ingredients (In each tablet): Bryonia 6X HPUS, Gelsemium sempervirens 6X, 12X, 30X HPUS, Sambucus nigra 3X, 6X HPUS, Sulphur 12X HPUS, Zincum gluconicum 2X, 6X HPUS * ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6

​Inactive Ingredients

Black carrot extract (colorant), Croscarmellose sodium, Elderberry flavor, Lactose, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Sucrose.

Section 51945-4

NDC 17312-077-30

Section 55105-1

Bryonia 6X HPUS.................................................Fever, chills, scratchy throat, muscle soreness

Gelsemium sempervirens 6X, 12X, 30X HPUS....Sneezing, non-productive cough, bronchial irritation

Sambucus nigra 3X, 6X HPUS.............................Fever, nasal congestion, coughing

Sulphur 12X HPUS...............................................Sinus pressure, sore throat, nasal pressure

Zincum gluconicum 2X, 6X HPUS........................Nausea, tiredness, exhaustion, bronchial constriction

Section 55106-9

​Active Ingredients (In each tablet):

Bryonia 6X HPUS, Gelsemium sempervirens 6X, 12X, 30X HPUS, Sambucus nigra 3X, 6X HPUS, Sulphur 12X HPUS, Zincum gluconicum 2X, 6X HPUS

* ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 60561-8

​Other Information

Do not use if blister seal is broken. • Store at room temperature 15 o to 30 o C (59 o to 86 o F). • 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 or contraindications. • Retain carton for full drug facts.


Structured Label Content

Indications and Usage (34067-9)

​Uses*

According to homeopathic indications, these ingredients provide temporary relief of cold and flu symptoms such as: • Nasal and sinus congestion, runny nose, sore throat, coughing, sneezing, and chills and fever, after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage and Administration (34068-7)

​Directions

• Suitable for adults and children ages 4 and over. Children under the age of 4: Consult a physician before use. • For best results, take at the start of the symptoms for cold or flu and continue to take for another 48 hours after the symptoms end. • Dissolve entire tablet under tongue. • Do not chew or swallow whole. • Take 1 tablet every three hours. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.

Warnings and Precautions (34071-1)

​Warnings

​A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. Sore throat warning - Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 4 years of age unless directed by 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.

If pregnant or breast feeding​, ask a health professional before using.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

​Inactive Ingredients

Black carrot extract (colorant), Croscarmellose sodium, Elderberry flavor, Lactose, Magnesium stearate, Maltodextrin, Microcrystalline cellulose, Sucrose.

Section 51945-4 (51945-4)

NDC 17312-077-30

Section 55105-1 (55105-1)

Bryonia 6X HPUS.................................................Fever, chills, scratchy throat, muscle soreness

Gelsemium sempervirens 6X, 12X, 30X HPUS....Sneezing, non-productive cough, bronchial irritation

Sambucus nigra 3X, 6X HPUS.............................Fever, nasal congestion, coughing

Sulphur 12X HPUS...............................................Sinus pressure, sore throat, nasal pressure

Zincum gluconicum 2X, 6X HPUS........................Nausea, tiredness, exhaustion, bronchial constriction

Section 55106-9 (55106-9)

​Active Ingredients (In each tablet):

Bryonia 6X HPUS, Gelsemium sempervirens 6X, 12X, 30X HPUS, Sambucus nigra 3X, 6X HPUS, Sulphur 12X HPUS, Zincum gluconicum 2X, 6X HPUS

* ​The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 60561-8 (60561-8)

​Other Information

Do not use if blister seal is broken. • Store at room temperature 15 o to 30 o C (59 o to 86 o F). • 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 or contraindications. • Retain carton for full drug facts.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)