Drug Facts:

Drug Facts:
SPL v10
SPL
SPL Set ID 4dc2088f-3f13-4e49-83e4-44c2a26d195f
Route
ORAL
Published
Effective Date 2024-11-04
Document Type 34390-5 HUMAN OTC 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 Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Sucrose European Elderberry Juice

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-03-26

Description

(in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.* *Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Bryonia – Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra – Nasal congestion, coughing, Sulphur – Nasal congestion and pressure, headache, Zincum Gluconicum – Fatigue, nausea, minor sore throat.


Medication Information

Purpose

Bryonia – Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra – Nasal congestion, coughing, Sulphur – Nasal congestion and pressure, headache, Zincum Gluconicum – Fatigue, nausea, minor sore throat.

Description

(in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.* *Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses:

• Temporarily relieves cold & flu symptoms.**

• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and

headache.**

• Also temporarily relieves body aches associated with the flu.**

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

Purpose:

Bryonia – Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra – Nasal congestion, coughing, Sulphur – Nasal congestion and pressure, headache, Zincum Gluconicum – Fatigue, nausea, minor sore throat.

Warnings:

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 3 years of age unless directed by a physician. Stop use and ask a doctor  if:

• Symptoms worsen  • Any new symptoms appear.

• Fever lasts for more than three days.

• Respiratory symptoms persist for more than seven days.

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

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

Do not use if blister seal is broken. 

Active Ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.

Questions:

Manufactured exclusively for

Pharmacare US, Inc.

San Diego, CA  92108

SambucolUSA.com  or

call 1-888-871-9098

Directions:

• For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.

Adults and children 12 years of age and older. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

Active Ingredients:

(in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.*

*Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients:

Black Carrot Extract (Colorant), Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.

Package Label Display:

NDC# 52053-0001-2

Sambucol®

BLACK ELDERBERRY

COLD & FLU RELIEF

FAST TEMPORARY RELIEF FROM:

√ NASAL CONGESTION  √ SORE THROAT

√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE  √ COUGH



30 TABLETS



HOMEOPATHIC

Keep Out of Reach of Children:

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


Structured Label Content

Uses: (USES:)

• Temporarily relieves cold & flu symptoms.**

• Provides temporary relief from respiratory symptoms such as sneezing, runny nose, nasal & sinus congestion, minor sore throat and

headache.**

• Also temporarily relieves body aches associated with the flu.**

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

Purpose: (PURPOSE:)

Bryonia – Muscle ache, headache, dry throat, cough, Gelsemium Sempervirens - Sneezing, Sambucus Nigra – Nasal congestion, coughing, Sulphur – Nasal congestion and pressure, headache, Zincum Gluconicum – Fatigue, nausea, minor sore throat.

Warnings: (WARNINGS:)

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 3 years of age unless directed by a physician. Stop use and ask a doctor  if:

• Symptoms worsen  • Any new symptoms appear.

• Fever lasts for more than three days.

• Respiratory symptoms persist for more than seven days.

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

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

Do not use if blister seal is broken. 

Active Ingredients are monographed and microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States.

Questions: (QUESTIONS:)

Manufactured exclusively for

Pharmacare US, Inc.

San Diego, CA  92108

SambucolUSA.com  or

call 1-888-871-9098

Directions: (DIRECTIONS:)

• For best results, use at the first sign of symptoms of a cold or flu and continue to use for an additional 48 hours after symptoms subside.

Adults and children 12 years of age and older. Dissolve entire tablet in mouth. Do not chew. Do not swallow whole. Take one tablet at the outset of symptoms. Repeat every three hours.

Active Ingredients: (ACTIVE INGREDIENTS:)

(in Each Tablet): Bryonia 6X,* Gelsemium Sempervirens 6X, 12X, 30X,* Sambucus Nigra 3X, 6X,* Sulphur 12X,* Zincum Gluconicum 2X, 6X.*

*Indicates the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Black Carrot Extract (Colorant), Croscarmellose Sodium, Elderberry Flavor, Lactose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Sucrose.

Package Label Display: (PACKAGE LABEL DISPLAY:)

NDC# 52053-0001-2

Sambucol®

BLACK ELDERBERRY

COLD & FLU RELIEF

FAST TEMPORARY RELIEF FROM:

√ NASAL CONGESTION  √ SORE THROAT

√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE  √ COUGH



30 TABLETS



HOMEOPATHIC

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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