COUGH AND COLD REAL 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

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

USES

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

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

DIRECTIONS

Do not use more than directed.

Do not take with food.

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

Adults and children 12+ yrs: 2 teaspoons (tsp)

Children 6 to 11 years of age: 1 teaspoon (tsp)

Children 2 to 5 years of age: 1/2 teaspoon (tsp)

OTHER INFORMATION

Store at room temperature.

Do not use if seal is broken or missing.

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 REAL RELIEF
drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, corrallium rubrum, stannum metallicum syrup

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:60512-9085
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 250 mL
ARNICA MONTANA (ARNICA MONTANA)	ARNICA MONTANA	3 [hp_C] in 250 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT)	BRYONIA ALBA ROOT	3 [hp_C] in 250 mL
IPECAC (IPECAC)	IPECAC	3 [hp_C] in 250 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (CETRARIA ISLANDICA SUBSP. ISLANDICA)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C] in 250 mL
ATROPA BELLADONNA (ATROPA BELLADONNA)	ATROPA BELLADONNA	3 [hp_C] in 250 mL
PROTORTONIA CACTI (PROTORTONIA CACTI)	PROTORTONIA CACTI	3 [hp_C] in 250 mL
CORALLIUM RUBRUM EXOSKELETON (CORALLIUM RUBRUM EXOSKELETON)	CORALLIUM RUBRUM EXOSKELETON	3 [hp_C] in 250 mL
TIN (TIN)	TIN	3 [hp_C] in 250 mL

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

#	Item Code	Package Description
Packaging
1	NDC:60512-9085-9	1 in 1 CARTON
1		250 mL in 1 BOTTLE
2	NDC:60512-9085-4	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2012

Labeler - HOMEOLAB USA INC (202032533)

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

Revised: 5/2012

Document Id: 8621be74-ef05-4b43-a1c7-f6c6d16e5fd8

Set id: cbc1d74b-2994-4f75-8483-3ec7dc0d5610

Version: 1

Effective Time: 20120528

HOMEOLAB USA INC