Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 7dace656-ee97-4931-869f-8c8022757abb
Route
ORAL
Published
Effective Date 2024-05-24
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 European Elderberry Juice Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Sucrose Maltodextrin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-10-04

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 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 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 using.

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.

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 United States.

Inactive Ingredients:

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

Package Label Display:

NDC 52053-0004-1

Sambucol

BLACK ELDERBERRY

COLD & FLU RELIEF

FAST TEMPORARY RELIEF FROM:

√ NASAL CONGESTION √ SORE THROAT

√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE √ COUGH



60 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 using.

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.

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 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 52053-0004-1

Sambucol

BLACK ELDERBERRY

COLD & FLU RELIEF

FAST TEMPORARY RELIEF FROM:

√ NASAL CONGESTION √ SORE THROAT

√ FEVER + CHILLS √ HEADACHE

√ RUNNY NOSE √ COUGH



60 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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