SPL v8
SPL
SPL Set ID de020891-eca2-405c-81cd-75dfb4ffe586
Route
ORAL
Published
Effective Date 2018-07-07
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]) Cetraria Islandica Subsp. Islandica Protortonia Cacti Tin Chamomile Arabica Coffee Bean Corallium Rubrum Whole
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 Arnica Montana 3C Bryonia 3C Cetraria islandica 3C Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C Chamomilla 4C Coffee 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

UsesThis 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 • Chidren under 6 months of age: Consult

a licensed healthcare professional before using this product

Children 6 months to 2 years old: 2.5ml or 1/2 teaspoon,

every 8 hours or 3 times a day • Children 2 to 12 years

old: 5ml or 1 teaspoon, every 8 hours or 3 times a day. 

Description

Active Ingredients HPUS Drosera 1C Arnica Montana 3C Bryonia 3C Cetraria islandica 3C Coccus cacti 3C Corallium rubrum 3C Stannum metallicum 3C Chamomilla 4C Coffee 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 ingredientsPurified 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

Cetraria islandica 3C...............cough with expectoration

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

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

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

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

Coffee crudea 4C....................restlessness and sleeplessness

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

monographed in the Homeopathic Pharmacopoeia of the United States

Section 55106-9

Active Ingredients HPUS

Drosera 1C

Arnica Montana 3C

Bryonia 3C

Cetraria islandica 3C

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Chamomilla 4C

Coffee crudea 4C


Structured Label Content

Indications and Usage (34067-9)

UsesThis 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 • Chidren under 6 months of age: Consult

a licensed healthcare professional before using this product

Children 6 months to 2 years old: 2.5ml or 1/2 teaspoon,

every 8 hours or 3 times a day • Children 2 to 12 years

old: 5ml 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 ingredientsPurified 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

Cetraria islandica 3C...............cough with expectoration

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

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

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

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

Coffee crudea 4C....................restlessness and sleeplessness

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

monographed in the Homeopathic Pharmacopoeia of the United States

Section 55106-9 (55106-9)

Active Ingredients HPUS

Drosera 1C

Arnica Montana 3C

Bryonia 3C

Cetraria islandica 3C

Coccus cacti 3C

Corallium rubrum 3C

Stannum metallicum 3C

Chamomilla 4C

Coffee crudea 4C


Advanced Ingredient Data


Raw Label Data

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