COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF- drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, corallium rubrum, stannum metallicum, chamomilla, coffea cruda syrup

COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF by

Drug Labeling and Warnings

COUGH AND COLD NIGHTTIME FORMULA KIDS 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

Cetraria islandica (Iceland moss) 1C

Belladonna (Deadly nightshade) 3C - Calculated as 0.0000003% alkaloids

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

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 traditionally used to help relieve symptoms associated with nighttime 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 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 8 hours or 3 times a day.

Children 2 to 12 years old: 5 ml or 1 teaspoon every 8 hours or 3 times a day.

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

INGREDIENTS AND APPEARANCE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-9081
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
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1) (CETRARIA ISLANDICA SUBSP. ISLANDICA - UNII:BJ7YPN79A1)	CETRARIA ISLANDICA SUBSP. ISLANDICA	1 [hp_C]  in 100 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	3 [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
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	4 [hp_C]  in 100 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	4 [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: 60512-9081-5	1 in 1 CARTON
1		100 mL in 1 BOTTLE
2	NDC: 60512-9081-4	30 mL in 1 BOTTLE
3	NDC: 60512-9081-9	1 in 1 CARTON
3		250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/28/2011

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-9081)