SPL v2
SPL
SPL Set ID ab37b0fd-cd18-4823-baef-dedadac86236
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 Cochineal Corallium Rubrum Whole Tin Protortonia Cacti 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 -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 -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 - Cough Cold Daytime Syrup DROSERA ROTUNDIFOLIA FLOWERING TOP                  Dry Cough ARNICA MONTANA                                                              Aches and Pain , Chest Congestion BRYONIA ALBA WHOLE                                                       Painful Cough IPECACUANHA (IPECAC)                                                   Night 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 - 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 - Cough Cold Daytime Syrup



DROSERA ROTUNDIFOLIA FLOWERING TOP                  Dry Cough

ARNICA MONTANA                                                              Aches and Pain , Chest Congestion

BRYONIA ALBA WHOLE                                                       Painful Cough

IPECACUANHA (IPECAC)                                                   Night 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 - 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 -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 -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 nighttime cough and cold*; dry cough, cough with expectorantion, chest congestion, aches and pain,fever.

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

Section 50565-1

Warnings

Stop use and ask a doctor if: • Pain & cough get worse or last more than 5 days (children) or 7 days (adults). • 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.

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

professional or poison control center immediately.

Directions

Part 1 Kids Relief Daytime Syrup

Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 6 hours or 4 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon, every 6 hours or 4 times a day.

Part 2 Kids Relief Nighttime Syrup

Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 8 hours or 3 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon, every 8 hours or 3 times a day.

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 -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 -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 nighttime cough and cold*; dry cough, cough with expectorantion, chest congestion, aches and pain,fever.

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

Section 50565-1 (50565-1)

Purpose

Part 1 - Cough Cold Daytime Syrup



DROSERA ROTUNDIFOLIA FLOWERING TOP                  Dry Cough

ARNICA MONTANA                                                              Aches and Pain , Chest Congestion

BRYONIA ALBA WHOLE                                                       Painful Cough

IPECACUANHA (IPECAC)                                                   Night 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 - 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 (children) or 7 days (adults). • 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.

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

professional or poison control center immediately.

Directions

Part 1 Kids Relief Daytime Syrup

Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 6 hours or 4 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon, every 6 hours or 4 times a day.

Part 2 Kids Relief Nighttime Syrup

Children under 6 months of age: consult a licensed healthcare practitioner before using the product. Children 6 months to 2 years old: 2.5 ml or ½ teaspoon, every 8 hours or 3 times a day. Children 2 to 12 years old: 5 ml or 1 teaspoon, every 8 hours or 3 times a day.

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 -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 -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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