Sambucol Cold And Flu Relief

Sambucol Cold And Flu Relief
SPL v2
SPL
SPL Set ID ce66e57d-ae46-0973-e053-2a95a90a6165
Route
ORAL
Published
Effective Date 2021-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: SCF Shape: round Color: purple Size: 10 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-10-15

Description

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

Purpose

Bryonia 6X................Muscle ache, headache, dry throat, cough Gelsemium sempervirens 6X, 12X, 30X.......................Sneezing Sambucus nigra 3X, 6X...................Nasal congestion, coughing Sulphur 12X....................Nasal congestion and pressure, headache Zincum gluconicum 2X, 6X..........................Fatigue, nausea, minor sore throat * The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Purpose

Bryonia 6X................Muscle ache, headache, dry throat, cough

Gelsemium sempervirens 6X, 12X, 30X.......................Sneezing

Sambucus nigra 3X, 6X...................Nasal congestion, coughing

Sulphur 12X....................Nasal congestion and pressure, headache

Zincum gluconicum 2X, 6X..........................Fatigue, nausea, minor sore throat

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

Description

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

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.
Section 50565-1

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

Section 50566-9

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
Section 50570-1

Do not use for children under 4 years of age.

Section 51945-4

NDC# 52053-0001-4

Sambucol

Black Elderberry

Cold & Flu Relief

90 Count Family Pack

Take at the first sign of cold and flu symptoms

**Temporary relief from:

  • Nasal & sinus congestion
  • Runny nose
  • Sore throat
  • Coughing
  • Sneezing

90 Tablets

Homeopathic

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

Section 53414-9

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

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.

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 4 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.

Other Information
  • Do not use if blister seal is broken

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

Active Ingredients

Bryonia 6X

Gelsemium sempervirens 6X, 12X, 30X

Sambucus nigra 3X, 6X

Sulphur 12X

Zincum gluconicum 2X, 6X

Inactive Ingredients

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


Structured Label Content

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.
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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
Section 50570-1 (50570-1)

Do not use for children under 4 years of age.

Section 51945-4 (51945-4)

NDC# 52053-0001-4

Sambucol

Black Elderberry

Cold & Flu Relief

90 Count Family Pack

Take at the first sign of cold and flu symptoms

**Temporary relief from:

  • Nasal & sinus congestion
  • Runny nose
  • Sore throat
  • Coughing
  • Sneezing

90 Tablets

Homeopathic

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

Section 53414-9 (53414-9)

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

Purpose

Bryonia 6X................Muscle ache, headache, dry throat, cough

Gelsemium sempervirens 6X, 12X, 30X.......................Sneezing

Sambucus nigra 3X, 6X...................Nasal congestion, coughing

Sulphur 12X....................Nasal congestion and pressure, headache

Zincum gluconicum 2X, 6X..........................Fatigue, nausea, minor sore throat

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

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.

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 4 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.

Other Information
  • Do not use if blister seal is broken

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

Active Ingredients

Bryonia 6X

Gelsemium sempervirens 6X, 12X, 30X

Sambucus nigra 3X, 6X

Sulphur 12X

Zincum gluconicum 2X, 6X

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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