COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF - drosera rotundifolia, arnica montana, bryonia alba root, cetraria islandica subsp. islandica, atropa belladonna, protortonia cacti, corallium rubrum exoskeleton, tin, matricaria recutita and arabica coffee bean 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

Drosera (Sundew) 1C

Arnica montana (Leopard`s bane) 3C

Bryonia (White bryony) 3C

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C

Chamomilla (German chamomile) 4C

Coffea cruda (Coffee) 4C

PURPOSE

Dry cough.

Aches and pains, chest congestion.

Painful cough.

Cough with expectoration.

Cold and fever.

Cough with expectoration.

Painful cough.

Mucus, cough and chills.

Restlessness, irritability and nocturnal awakenings.

Restlessness and sleeplessness.

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

USES

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

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

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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.

Take before bedtime. Repeat every 8 hours, as needed. Reduce intake 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

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LABEL

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COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF 
drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, corallium rubrum, stannum metallicum, chamomilla, coffea cruda syrup
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60512-9081
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DROSERA ROTUNDIFOLIA (DROSERA ROTUNDIFOLIA) DROSERA ROTUNDIFOLIA1 [hp_C]  in 100 mL
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA3 [hp_C]  in 100 mL
BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT3 [hp_C]  in 100 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (CETRARIA ISLANDICA SUBSP. ISLANDICA) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 100 mL
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA3 [hp_C]  in 100 mL
PROTORTONIA CACTI (PROTORTONIA CACTI) PROTORTONIA CACTI3 [hp_C]  in 100 mL
CORALLIUM RUBRUM EXOSKELETON (CORALLIUM RUBRUM EXOSKELETON) CORALLIUM RUBRUM EXOSKELETON3 [hp_C]  in 100 mL
TIN (TIN) TIN3 [hp_C]  in 100 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA) MATRICARIA RECUTITA4 [hp_C]  in 100 mL
ARABICA COFFEE BEAN (ARABICA COFFEE BEAN) ARABICA COFFEE BEAN4 [hp_C]  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
CARAMEL 
SODIUM BENZOATE 
POTASSIUM SORBATE 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9081-51 in 1 CARTON
1100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/28/2011
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture

Revised: 1/2011
Document Id: 381c5753-af22-475f-9a34-ef92cc67d688
Set id: beff0858-ed6c-49e2-b8b2-76d2b08b288e
Version: 1
Effective Time: 20110111
 
HOMEOLAB USA INC