SPL v2
SPL
SPL Set ID da5677ec-63fd-4467-9755-479d0ab51df5
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 Arnica montana 3C Bryonia 3C Ipecacuanha 3C Cetraria islandica 1C    Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C Camomilla 4C Coffea crudea 4C


Medication Information

Warnings and Precautions

Warnings

Stop use and ask a doctor if •pain or cough gets worse

or lasts 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

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 •Children under 6 months of age: Consult a

licensed healthcare practitioner before using this product

Children 6 months to 2 years old: 2.5 ml or 1.2 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

Description

Active Ingredients HPUS: Drosera 1C Arnica montana 3C Bryonia 3C Ipecacuanha 3C Cetraria islandica 1C    Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C Camomilla 4C Coffea crudea 4C

Section 44425-7

Other information •Store at room temperature.

•do not use if seal is broken or missing

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

Arnica montana 3C

Bryonia 3C

Ipecacuanha 3C

Cetraria islandica 1C   

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Camomilla 4C

Coffea crudea 4C


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 •Children under 6 months of age: Consult a

licensed healthcare practitioner before using this product

Children 6 months to 2 years old: 2.5 ml or 1.2 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

Warnings and Precautions (34071-1)

Warnings

Stop use and ask a doctor if •pain or cough gets worse

or lasts 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

Section 44425-7 (44425-7)

Other information •Store at room temperature.

•do not use if seal is broken or missing

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

Arnica montana 3C

Bryonia 3C

Ipecacuanha 3C

Cetraria islandica 1C   

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Camomilla 4C

Coffea crudea 4C


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)