SPL v5
SPL
SPL Set ID dd9a33c7-2d6a-434f-acf4-0cdad467537d
Route
ORAL
Published
Effective Date 2023-11-13
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 Ipecac Cetraria Islandica Subsp. Islandica Protortonia Cacti Corallium Rubrum Whole Tin
Inactive Ingredients
Water Sorbitol Caramel Sodium Benzoate Potassium Sorbate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-03-03

Description

Active Ingredients HPUS: Drosera 1C (Sundew) Arnica montana 3C (Leopard's Bane) Bryonia 3C (White Bryony) Ipecacuanha 3C (Ipecac) Cetraria islandica 1C (Iceland Moss) Coccus cacti 3C (Cochineal) Corallium rubrum 3C (Red Coral) Stannum metallicum 3C (Tin) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States


Medication Information

Warnings and Precautions

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 a 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 use. 

Indications and Usage

Uses:  This homeopathic medicine is made from a combination of

ingredients traditionally used to help symptoms assiciated with 

cough and cold*  •dry cough  •expectorant cough  •chest

congestion  •fever  •aches and pains

Dosage and Administration

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

food  •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 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 (Leopard's Bane) Bryonia 3C (White Bryony) Ipecacuanha 3C (Ipecac) Cetraria islandica 1C (Iceland Moss) Coccus cacti 3C (Cochineal) Corallium rubrum 3C (Red Coral) Stannum metallicum 3C (Tin) The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

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 poison control center immediately. 

Section 51727-6

Inactive Ingredients:Purified water, sorbitol, caramel, sodium benzoate,

potassium sorbate, citric acid

Section 55105-1

Purpose

Drosera 1C (Sundew)...............................................dry cough

Arnica montana 3C (Leopard's Bane)..........................aches and pains, chest congestion

Bryonia 3C (White Bryony).......................................painful cough

Ipecacuanha 3C (Ipecac).........................................dry cough

Cetraria islandica 1C (Iceland Moss)..........................cough with expectoration

Coccus cacti 3C (Cochineal).....................................cough with expectoration

Corallium rubrum 3C (Red Coral)..............................painful cough

Stannum metallicum 3C (Tin)..................................coughs, chills and lessens mucus

Section 55106-9

Active Ingredients HPUS:

Drosera 1C (Sundew)

Arnica montana 3C (Leopard's Bane)

Bryonia 3C (White Bryony)

Ipecacuanha 3C (Ipecac)

Cetraria islandica 1C (Iceland Moss)

Coccus cacti 3C (Cochineal)

Corallium rubrum 3C (Red Coral)

Stannum metallicum 3C (Tin)

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

monographed in the Homeopathic Pharmacopoeia of the United States

Product Label


Structured Label Content

Indications and Usage (34067-9)

Uses:  This homeopathic medicine is made from a combination of

ingredients traditionally used to help symptoms assiciated with 

cough and cold*  •dry cough  •expectorant cough  •chest

congestion  •fever  •aches and pains

Dosage and Administration (34068-7)

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

food  •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 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 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 a 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 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 poison control center immediately. 

Section 51727-6 (51727-6)

Inactive Ingredients:Purified water, sorbitol, caramel, sodium benzoate,

potassium sorbate, citric acid

Section 55105-1 (55105-1)

Purpose

Drosera 1C (Sundew)...............................................dry cough

Arnica montana 3C (Leopard's Bane)..........................aches and pains, chest congestion

Bryonia 3C (White Bryony).......................................painful cough

Ipecacuanha 3C (Ipecac).........................................dry cough

Cetraria islandica 1C (Iceland Moss)..........................cough with expectoration

Coccus cacti 3C (Cochineal).....................................cough with expectoration

Corallium rubrum 3C (Red Coral)..............................painful cough

Stannum metallicum 3C (Tin)..................................coughs, chills and lessens mucus

Section 55106-9 (55106-9)

Active Ingredients HPUS:

Drosera 1C (Sundew)

Arnica montana 3C (Leopard's Bane)

Bryonia 3C (White Bryony)

Ipecacuanha 3C (Ipecac)

Cetraria islandica 1C (Iceland Moss)

Coccus cacti 3C (Cochineal)

Corallium rubrum 3C (Red Coral)

Stannum metallicum 3C (Tin)

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

monographed in the Homeopathic Pharmacopoeia of the United States

Product Label (Product label)


Advanced Ingredient Data


Raw Label Data

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