SPL v5
SPL
SPL Set ID fe18547a-0212-4cdf-accd-566ef122ff27
Route
ORAL
Published
Effective Date 2018-08-24
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 Subsp. Islandica Protortonia Cacti Corallium Rubrum Whole Tin Chamomile Arabica Coffee Bean
Inactive Ingredients
Water Sorbitol Caramel Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-05-03

Description

Active Ingredients HPUS: Drosera 1C (Sundew) Arnica montana 3C (Leopards Bane) Bryonia 3C (Whte Bryony) Ipecacuanha 3C (Ipecac) Cetraria islandica 1C   (Iceland Moss) Coccus cacti 3C (Cochineal) Corallium rubrum 3C (Red Coral) Stannum metallicum 3C (Tin) Camomilla 4C (German Chamomille) Coffea crudea 4C (coffee)   


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if •Pain & cough gets worse

or lasts 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 breastfeeding, ask a health professional before use.

Indications and Usage

Uses This homeopathic medicine is made from a combination

of ingredients traditionally used to help relieve

symptoms associated with nighttime cough and cold*:

•dry cough  •cough with expectoration

•chest congestion  •fever  •aches and pains

Dosage and Administration

Directions •Do not exceed recommended dosage  •Do not take with

food  •Take before bedtime.  Repeat every 8 hours as needed and reduce

with improvement or as directed by a health care professional.

Age..................................................................... Dose

Adults and Children 12 + years...............................10 ml or 2 teaspoons (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 1/2 teaspoon (tsp)

Description

Active Ingredients HPUS: Drosera 1C (Sundew) Arnica montana 3C (Leopards Bane) Bryonia 3C (Whte Bryony) Ipecacuanha 3C (Ipecac) Cetraria islandica 1C   (Iceland Moss) Coccus cacti 3C (Cochineal) Corallium rubrum 3C (Red Coral) Stannum metallicum 3C (Tin) Camomilla 4C (German Chamomille) Coffea crudea 4C (coffee)   

Section 44425-7

Other information •do not use if seal is broken or missing

•Store at room temperature.

Section 50565-1

Keep out of reach of children.In case of accidental

overdose, contact a medical professional or a poison 

control center immediately. 

Section 51727-6

Inactive ingredients  Purified water, sorbitol, 

caramel, sodium benzoate, potassium sorbate, citric acid

Section 51945-4

Section 55105-1

Purpose

Drosera 1C......................................dry cough

Arnica montana 3C...........................aches and pains, chest congestion

Bryonia 3C......................................painful cough

Ipecacuanha 3C...............................night cough

Cetraria islandica 1C.........................cough with expectoration

Coccus cacti 3C................................cough with expectoration

Corallium rubrum 3C.........................painful cough

Stannum metallicum 3C.....................cough, chills, and lessens mucus

Camomilla 4C...................................restlessness, irritability, nocturnal awakenings

Coffea crudea 4C..............................restlessness and sleeplessness

The letters "HPUS" indicate that the components in this product are officially

monographed in the Homeopathic Pharcopoeia of the United States

Section 55106-9

Active Ingredients HPUS:

Drosera 1C (Sundew)

Arnica montana 3C (Leopards Bane)

Bryonia 3C (Whte Bryony)

Ipecacuanha 3C (Ipecac)

Cetraria islandica 1C   (Iceland Moss)

Coccus cacti 3C (Cochineal)

Corallium rubrum 3C (Red Coral)

Stannum metallicum 3C (Tin)

Camomilla 4C (German Chamomille)

Coffea crudea 4C (coffee)   


Structured Label Content

Indications and Usage (34067-9)

Uses This homeopathic medicine is made from a combination

of ingredients traditionally used to help relieve

symptoms associated with nighttime cough and cold*:

•dry cough  •cough with expectoration

•chest congestion  •fever  •aches and pains

Dosage and Administration (34068-7)

Directions •Do not exceed recommended dosage  •Do not take with

food  •Take before bedtime.  Repeat every 8 hours as needed and reduce

with improvement or as directed by a health care professional.

Age..................................................................... Dose

Adults and Children 12 + years...............................10 ml or 2 teaspoons (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 1/2 teaspoon (tsp)

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if •Pain & cough gets worse

or lasts 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 breastfeeding, ask a health professional before use.

Section 44425-7 (44425-7)

Other information •do not use if seal is broken or missing

•Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children.In case of accidental

overdose, contact a medical professional or a poison 

control center immediately. 

Section 51727-6 (51727-6)

Inactive ingredients  Purified water, sorbitol, 

caramel, sodium benzoate, potassium sorbate, citric acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Drosera 1C......................................dry cough

Arnica montana 3C...........................aches and pains, chest congestion

Bryonia 3C......................................painful cough

Ipecacuanha 3C...............................night cough

Cetraria islandica 1C.........................cough with expectoration

Coccus cacti 3C................................cough with expectoration

Corallium rubrum 3C.........................painful cough

Stannum metallicum 3C.....................cough, chills, and lessens mucus

Camomilla 4C...................................restlessness, irritability, nocturnal awakenings

Coffea crudea 4C..............................restlessness and sleeplessness

The letters "HPUS" indicate that the components in this product are officially

monographed in the Homeopathic Pharcopoeia of the United States

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Drosera 1C (Sundew)

Arnica montana 3C (Leopards Bane)

Bryonia 3C (Whte Bryony)

Ipecacuanha 3C (Ipecac)

Cetraria islandica 1C   (Iceland Moss)

Coccus cacti 3C (Cochineal)

Corallium rubrum 3C (Red Coral)

Stannum metallicum 3C (Tin)

Camomilla 4C (German Chamomille)

Coffea crudea 4C (coffee)   


Advanced Ingredient Data


Raw Label Data

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