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

KIDS RELIEF COUGH AND COLD by

Drug Labeling and Warnings

KIDS RELIEF COUGH AND COLD 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

Coccus cacti (Cochineal) 3C

Corallium rubrum (Red coral) 3C

Stannum metallicum (Tin) 3C

Purpose

Dry cough

Aches and pains, chest congestion

Painful cough, fever

Night cough

Cough with expectoration

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 Homoeopathic 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 tracitionally used tohelp 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.

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

Directions

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 6 months to 2 years old: 2.5 ml or 1/2 teaspoon every 6 hours or 4 times a day.

Children 2 to 12 years old: 5 ml or 1 teaspoon every 6 hours or 4 times a day.

Other information

Store at room temperature.

Do not use if seal under bottle cap is broken or missing.

Inactive ingredients

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

CARTON

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-9210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DROSERA ROTUNDIFOLIA FLOWERING TOP (UNII: 75O014T1HG) (DROSERA ROTUNDIFOLIA FLOWERING TOP - UNII:75O014T1HG)	DROSERA ROTUNDIFOLIA FLOWERING TOP	1 [hp_C]  in 100 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_C]  in 100 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	3 [hp_C]  in 100 mL
IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L)	IPECAC	3 [hp_C]  in 100 mL
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C]  in 100 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	3 [hp_C]  in 100 mL
CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE)	CORALLIUM RUBRUM EXOSKELETON	3 [hp_C]  in 100 mL
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C]  in 100 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: 60512-9210-5	1 in 1 CARTON	11/01/2016
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 60512-9210-4	1 in 1 CARTON	11/04/2016
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 60512-9210-9	1 in 1 CARTON	11/04/2016
3		250 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/01/2016

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-9210)