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

Stannum metallicum (Tin) 3C

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

PURPOSE

Dry cough.

Aches and pains, chest congestion.

Painful cough.

Night cough.

Cough with expectoration.

Cold and fever.

Cough with expectoration.

Cough, chills and lessens mucus.

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.

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.

AGEDose
Children 6 years of age and older1 teaspoon
Children 2 to 5 years of age 1/2 teaspoon
Children under 2 years of age Ask a Doctor

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

COUGH AND COLD KIDS RELIEF 
drosera, arnica montana, bryonia, ipecacuanha, cetraria islandica, belladonna, coccus cacti, stannum metallicum syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA1 [hp_C]  in 250 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_C]  in 250 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT3 [hp_C]  in 250 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC3 [hp_C]  in 250 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1) CETRARIA ISLANDICA SUBSP. ISLANDICA1 [hp_C]  in 250 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA3 [hp_C]  in 250 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI3 [hp_C]  in 250 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5) TIN3 [hp_C]  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
CARAMEL (UNII: T9D99G2B1R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9011-5100 mL in 1 BOTTLE
2NDC:60512-9011-430 mL in 1 BOTTLE
3NDC:60512-9011-9250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/08/2012
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-9011)

Revised: 8/2012
Document Id: 1f56545f-3b70-41da-a1cb-8fa35ac8dec5
Set id: 24537ef5-8527-4b7e-b51d-63b9e2497c9e
Version: 1
Effective Time: 20120808
 
HOMEOLAB USA INC