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

Cough and Cold Real Relief by

Drug Labeling and Warnings

Cough and Cold Real Relief by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

REFERENCES

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

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help 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 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.

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

Keep out of reach of children. In case of accidenal overdose, contact a medical professional or a poison control center immediately.

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 health professional.

Age:                                         Dose:

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

LABEL

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 60512-9085
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ)	DROSERA ROTUNDIFOLIA	1 [hp_C]  in 250 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]  in 250 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_C]  in 250 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_C]  in 250 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C]  in 250 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [hp_C]  in 250 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	3 [hp_C]  in 250 mL
CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE)	CORALLIUM RUBRUM EXOSKELETON	3 [hp_C]  in 250 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C]  in 250 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CARAMEL (UNII: T9D99G2B1R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/17/2012

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-9085)