SPL v2
SPL
SPL Set ID b97993b4-54ab-41af-b385-227a25e64c6b
Route
ORAL
Published
Effective Date 2023-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Drosera Rotundifolia Flowering Top (1 [hp_C]) Arnica Montana (3 [hp_C]) Bryonia Alba Whole (4 [hp_C]) Ipecac Cetraria Islandica Whole Protortonia Cacti Corallium Rubrum Whole Tin Chamomile Arabica Coffee Bean
Inactive Ingredients
Water Caramel Sorbitol Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2022-09-01

Description

Part 1 -Real Relief Natural Wellness™ Cough Cold Daytime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP ARNICA MONTANA BRYONIA ALBA WHOLE IPECACUANHA (IPECAC) CETRARIA ISLANDICA SUBSP. ISLANDICA COCHINEAL (COCCUS CACTI) CORALLIUM RUBRUM WHOLE STANNUM METALLICUM (TIN) Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP ARNICA MONTANA BRYONIA ALBA WHOLE CETRARIA ISLANDICA SUBSP. ISLANDICA COCHINEAL (COCCUS CACTI) CORALLIUM RUBRUM WHOLE STANNUM METALLICUM (TIN) CHAMOMILLA (GERMAN CHAMOMILLE) COFFEA CRUDA (COFFEE)

Purpose

Part 1 - Real Relief Natural Wellness™ Cough Cold Daytime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough ARNICA MONTANA                                                                         Aches and Pain , Chest Congestion BRYONIA ALBA WHOLE                                                                  Painful Cough IPECACUANHA (IPECAC)                                                                Dry Cough CETRARIA ISLANDICA SUBSP. ISLANDICA                                       Cough With Expectoration COCHINEAL (COCCUS CACTI)                                                        Cough With Expectoration CORALLIUM RUBRUM WHOLE                                                         Painful cough STANNUM METALLICUM (TIN)                                                        Cough, Chills and Lessen mucus Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough ARNICA MONTANA                                                                         Aches and Pain , Chest Congestion BRYONIA ALBA WHOLE                                                                  Painful Cough CETRARIA ISLANDICA SUBSP. ISLANDICA                                       Cough With Expectoration COCHINEAL (COCCUS CACTI)                                                         Cough With Expectoration CORALLIUM RUBRUM WHOLE                                                          Painful cough STANNUM METALLICUM (TIN)                                                         Cough, Chills and Lessen mucus CHAMOMILLA (GERMAN CHAMOMILLE)                                            Restlessness, irritability and nocturnal awakening COFFEA CRUDA (COFFEE)                                                              Restlessness and sleeplessness The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.


Medication Information

Purpose

Part 1 - Real Relief Natural Wellness™ Cough Cold Daytime Syrup



DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough

ARNICA MONTANA                                                                         Aches and Pain , Chest Congestion

BRYONIA ALBA WHOLE                                                                  Painful Cough

IPECACUANHA (IPECAC)                                                                Dry Cough

CETRARIA ISLANDICA SUBSP. ISLANDICA                                       Cough With Expectoration

COCHINEAL (COCCUS CACTI)                                                        Cough With Expectoration

CORALLIUM RUBRUM WHOLE                                                         Painful cough

STANNUM METALLICUM (TIN)                                                        Cough, Chills and Lessen mucus

Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup



DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough

ARNICA MONTANA                                                                         Aches and Pain , Chest Congestion

BRYONIA ALBA WHOLE                                                                  Painful Cough

CETRARIA ISLANDICA SUBSP. ISLANDICA                                       Cough With Expectoration

COCHINEAL (COCCUS CACTI)                                                         Cough With Expectoration

CORALLIUM RUBRUM WHOLE                                                          Painful cough

STANNUM METALLICUM (TIN)                                                         Cough, Chills and Lessen mucus

CHAMOMILLA (GERMAN CHAMOMILLE)                                            Restlessness, irritability and nocturnal awakening

COFFEA CRUDA (COFFEE)                                                              Restlessness and sleeplessness

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

Description

Part 1 -Real Relief Natural Wellness™ Cough Cold Daytime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP ARNICA MONTANA BRYONIA ALBA WHOLE IPECACUANHA (IPECAC) CETRARIA ISLANDICA SUBSP. ISLANDICA COCHINEAL (COCCUS CACTI) CORALLIUM RUBRUM WHOLE STANNUM METALLICUM (TIN) Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP ARNICA MONTANA BRYONIA ALBA WHOLE CETRARIA ISLANDICA SUBSP. ISLANDICA COCHINEAL (COCCUS CACTI) CORALLIUM RUBRUM WHOLE STANNUM METALLICUM (TIN) CHAMOMILLA (GERMAN CHAMOMILLE) COFFEA CRUDA (COFFEE)

Uses

T his ho meo pathic medicine is made from a combination of ingredients traditionally used to help symptoms associated with cough and cold*; dry cough, expectorant cough, chest congestion, fever, aches and pain.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Section 50565-1

Warnings

Stop use and ask a doctor if: • Pain & cough get worse or last more than 5 days. • Fever gets worse or lasts more than 3 days. • Redness or swelling is present. • New symptoms occur. • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, contact a medical

professional or poison control center immediately.

Directions

Part 1 Real Relief Natural Wellness™ Daytime Syrup

Directions:

• Do not exceed recommended dosage

• Do not take with foods

• Repeat every 4 hours and reduce with improvement or as directed by a health professional.

Age………………………………………………………….Dose

Adults and Children 12 + years. ...........10 ml or 2 teaspoon (tsp)

Children 6 to 11 years of age. ...............5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age. .................2.5 ml or ½ teaspoon (tsp)

Part 2 Real Relief Natural Wellness™ Relief Nighttime Syrup

Directions:

• Do not exceed recommended dosage

• Do not take with foods

• Repeat every 8 hours and reduce with improvement or as directed by a health professional.

Age………………………………………………………….Dose

Adults and Children 12 + years. ............10 ml or 2 teaspoon (tsp)

Children 6 to 11 years of age. ................5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age. ..................2.5 ml or ½ teaspoon (tsp)

Product Label

Other Information

Part 1

Do not use if the seal is broken or missing. Store at room temperature.

Part 2

Store at room temperature.• Do not use if seal is broken or missing

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Active Ingredients

Part 1 -Real Relief Natural Wellness™ Cough Cold Daytime Syrup

DROSERA ROTUNDIFOLIA FLOWERING TOP

ARNICA MONTANA

BRYONIA ALBA WHOLE

IPECACUANHA (IPECAC)

CETRARIA ISLANDICA SUBSP. ISLANDICA

COCHINEAL (COCCUS CACTI)

CORALLIUM RUBRUM WHOLE

STANNUM METALLICUM (TIN)

Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup

DROSERA ROTUNDIFOLIA FLOWERING TOP

ARNICA MONTANA

BRYONIA ALBA WHOLE

CETRARIA ISLANDICA SUBSP. ISLANDICA

COCHINEAL (COCCUS CACTI)

CORALLIUM RUBRUM WHOLE

STANNUM METALLICUM (TIN)

CHAMOMILLA (GERMAN CHAMOMILLE)

COFFEA CRUDA (COFFEE)

Inactive Ingredients

Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.


Structured Label Content

Uses

T his ho meo pathic medicine is made from a combination of ingredients traditionally used to help symptoms associated with cough and cold*; dry cough, expectorant cough, chest congestion, fever, aches and pain.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Section 50565-1 (50565-1)

Purpose

Part 1 - Real Relief Natural Wellness™ Cough Cold Daytime Syrup



DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough

ARNICA MONTANA                                                                         Aches and Pain , Chest Congestion

BRYONIA ALBA WHOLE                                                                  Painful Cough

IPECACUANHA (IPECAC)                                                                Dry Cough

CETRARIA ISLANDICA SUBSP. ISLANDICA                                       Cough With Expectoration

COCHINEAL (COCCUS CACTI)                                                        Cough With Expectoration

CORALLIUM RUBRUM WHOLE                                                         Painful cough

STANNUM METALLICUM (TIN)                                                        Cough, Chills and Lessen mucus

Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup



DROSERA ROTUNDIFOLIA FLOWERING TOP Dry Cough

ARNICA MONTANA                                                                         Aches and Pain , Chest Congestion

BRYONIA ALBA WHOLE                                                                  Painful Cough

CETRARIA ISLANDICA SUBSP. ISLANDICA                                       Cough With Expectoration

COCHINEAL (COCCUS CACTI)                                                         Cough With Expectoration

CORALLIUM RUBRUM WHOLE                                                          Painful cough

STANNUM METALLICUM (TIN)                                                         Cough, Chills and Lessen mucus

CHAMOMILLA (GERMAN CHAMOMILLE)                                            Restlessness, irritability and nocturnal awakening

COFFEA CRUDA (COFFEE)                                                              Restlessness and sleeplessness

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

Warnings

Stop use and ask a doctor if: • Pain & cough get worse or last more than 5 days. • Fever gets worse or lasts more than 3 days. • Redness or swelling is present. • New symptoms occur. • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

Keep out of reach of children. In case of accidental overdose, contact a medical

professional or poison control center immediately.

Directions

Part 1 Real Relief Natural Wellness™ Daytime Syrup

Directions:

• Do not exceed recommended dosage

• Do not take with foods

• Repeat every 4 hours and reduce with improvement or as directed by a health professional.

Age………………………………………………………….Dose

Adults and Children 12 + years. ...........10 ml or 2 teaspoon (tsp)

Children 6 to 11 years of age. ...............5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age. .................2.5 ml or ½ teaspoon (tsp)

Part 2 Real Relief Natural Wellness™ Relief Nighttime Syrup

Directions:

• Do not exceed recommended dosage

• Do not take with foods

• Repeat every 8 hours and reduce with improvement or as directed by a health professional.

Age………………………………………………………….Dose

Adults and Children 12 + years. ............10 ml or 2 teaspoon (tsp)

Children 6 to 11 years of age. ................5 ml or 1 teaspoon (tsp)

Children 2 to 5 years of age. ..................2.5 ml or ½ teaspoon (tsp)

Product Label (Product label)

Other Information (Other information)

Part 1

Do not use if the seal is broken or missing. Store at room temperature.

Part 2

Store at room temperature.• Do not use if seal is broken or missing

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice, not medical evidence.

Active Ingredients

Part 1 -Real Relief Natural Wellness™ Cough Cold Daytime Syrup

DROSERA ROTUNDIFOLIA FLOWERING TOP

ARNICA MONTANA

BRYONIA ALBA WHOLE

IPECACUANHA (IPECAC)

CETRARIA ISLANDICA SUBSP. ISLANDICA

COCHINEAL (COCCUS CACTI)

CORALLIUM RUBRUM WHOLE

STANNUM METALLICUM (TIN)

Part 2 - Real Relief Natural Wellness™ Cough Cold Nighttime Syrup

DROSERA ROTUNDIFOLIA FLOWERING TOP

ARNICA MONTANA

BRYONIA ALBA WHOLE

CETRARIA ISLANDICA SUBSP. ISLANDICA

COCHINEAL (COCCUS CACTI)

CORALLIUM RUBRUM WHOLE

STANNUM METALLICUM (TIN)

CHAMOMILLA (GERMAN CHAMOMILLE)

COFFEA CRUDA (COFFEE)

Inactive Ingredients (Inactive ingredients)

Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.


Advanced Ingredient Data


Raw Label Data

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