COUGH AND COLD NIGHTTIME FORMULA KIDS RELIEF- drosera, arnica montana, bryonia, cetraria islandica, belladonna, coccus cacti, 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 INGREDIENT

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

Stannum metallicum (Tin) 3C

Chamomilla (German chamomile) 4C

Coffea cruda (Coffee) 4C

REFERENCES

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

PURPOSE

Dry cough.

Aches and pains, chest congestion.

Painful cough.

Cough with expectoration.

Cold and fever.

Cough with expectoration.

Mucus, cough and chills.

Restlessness, irritability and nocturnal awakenings.

Restlessness and sleeplessness.

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

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.

• Age: Dose
• Children 6 years of age and older: 1 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-9021
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 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
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: 60512-9021-9	250 mL in 1 BOTTLE
2	NDC: 60512-9021-5	100 mL in 1 BOTTLE
3	NDC: 60512-9021-4	30 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(60512-9021)