COUGH AND COLD KIDS RELIEF - drosera rotundifolia, arnica montana, bryonia alba root, ipecac, cetraria islandica subsp. islandica, atropa belladonna, protortonia cacti, corallium rubrum exoskeleton and tin syrup
HOMEOLAB USA INC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS

ACTIVE INGREDIENTS HPUS

Drosera (Sundew) 1C

Arnica montana (Leopard`s bane) 3C

Bryonia (White bryony) 3C

Ipecacuanha (Ipecac) 3C

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C

PURPOSE

Dry cough.

Aches and pains, chest congestion.

Painful cough.

Night cough.

Cough with expectoration.

Cold and fever.

Cough with expectoration.

Painful cough.

Cough, chills and lessens mucus.

This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).

USES

This homeopathic medicine helps relieve symptoms associated with cough and cold:

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

Do not use if seal is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 5 days.

Keep out of reach of children.

DIRECTIONS

Do not use more than directed.

Do not take with food.

Repeat every 4 hours and reduce with improvement or as directed by a healthcare professional.

Children 6 years of age and older: 1 teaspoon.

Children 2 to 5 years of age: 1/2 teaspoon.

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

Purified water, sorbitol, caramel, sodium benzoate, potassium sorbate, citric acid.

CARTON

image of carton label

LABEL

image of bottle label

COUGH AND COLD KIDS RELIEF
drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, corallium rubrum, stannum metallicum syrup

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:60512-9061
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DROSERA ROTUNDIFOLIA (DROSERA ROTUNDIFOLIA)	DROSERA ROTUNDIFOLIA	1 [hp_C] in 100 mL
ARNICA MONTANA (ARNICA MONTANA)	ARNICA MONTANA	3 [hp_C] in 100 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT)	BRYONIA ALBA ROOT	3 [hp_C] in 100 mL
IPECAC (IPECAC)	IPECAC	3 [hp_C] in 100 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (CETRARIA ISLANDICA SUBSP. ISLANDICA)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C] in 100 mL
ATROPA BELLADONNA (ATROPA BELLADONNA)	ATROPA BELLADONNA	3 [hp_C] in 100 mL
PROTORTONIA CACTI (PROTORTONIA CACTI)	PROTORTONIA CACTI	3 [hp_C] in 100 mL
CORALLIUM RUBRUM EXOSKELETON (CORALLIUM RUBRUM EXOSKELETON)	CORALLIUM RUBRUM EXOSKELETON	3 [hp_C] in 100 mL
TIN (TIN)	TIN	3 [hp_C] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
SORBITOL
CARAMEL
SODIUM BENZOATE
POTASSIUM SORBATE
CITRIC ACID MONOHYDRATE

#	Item Code	Package Description
Packaging
1	NDC:60512-9061-5	1 in 1 CARTON
1		100 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/18/2008

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture

Revised: 6/2010

Document Id: 5372d20e-9c18-48cb-a9e1-fcb725a67260

Set id: 0e322d11-3f15-4dbb-8c76-f00155340d4b

Version: 1

Effective Time: 20100601

HOMEOLAB USA INC