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

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

The letters HPUS indicate the ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

USES

This homeopathic medecine helps relieve symptoms associated with nighttime cough and cold:

- dry cough

- cough with expectoration

- chest congestion

- fever

- aches and pains

WARNINGS

Do not use if seal is broken or missing.

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.

Adults and children 12+ yrs: 2 teaspoons.

Children 6 to 11 years of age: 1 teaspoon.

Children 2 to 5 years of age: 1/2 teaspoon.

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

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

CARTON

image of carton label

LABEL

image of bottle label

COUGH AND COLD NIGHTTIME REAL 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:60512-9084
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
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
TIN (UNII: 387GMG9FH5) (TIN - UNII:387GMG9FH5)	TIN	3 [hp_C] in 250 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	4 [hp_C] in 250 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	4 [hp_C] in 250 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60512-9084-9	1 in 1 CARTON	03/21/2012
1		250 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/21/2012

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(60512-9084)

DRUG FACTS