ACTIVE INGREDIENTS HPUS

Asafoetida (Asafetida) 8X

Ignatia amara (Ignatius bean) 8X

Valeriana officinalis (Valerian) 8X

Avena sativa (Oats) 8X

Argentum nitricum (Silver nitrate) 8X

Tarentula hispana (Tarantula) 8X

Hyoscyamus niger (Henbane) 8X

Paeonia officinalis (Peony) 8X

Stramonium (Thorn apple) 8X

Cocculus indicus (Indian berry) 8X

PURPOSE

Restlessness and anxiety.

Nervousness.

Agitation.

Sleeplessness.

Nervousness.

Nightmares.

Anguish and fear.

Apprehension, anxiety and irritability.

Nightmares and nervousness.

Lack of concentration.

This product is manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS).

USES

This homeopathic medicine helps relieve:

- restlessness

- nervousness

- irritability

- agitation

- sleeplessness

- lessens nightmares.

WARNINGS

Do not use if seal is broken or missing.

Stop use and ask a doctor if symptoms worsen.

Keep out of reach of children.

DIRECTIONS

Do not use more than directed.

Do not take with food.

Repeat every 4 hours and reduce with improvement or as directed by a healthcare professional.

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.

INACTIVE INGREDIENTS

Purified water, sorbitol, grape and raspberry flavor, sodium benzoate, potassium sorbate, citric acid.

CARTON

image of carton label

LABEL

image of bottle label

CALM KIDS RELIEF
asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, tarentula hispana, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60512-9064
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASAFETIDA (UNII: W9FZA51AS1) (ASAFETIDA - UNII:W9FZA51AS1)	ASAFETIDA	8 [hp_X] in 100 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	8 [hp_X] in 100 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	8 [hp_X] in 100 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	8 [hp_X] in 100 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A)	SILVER NITRATE	8 [hp_X] in 100 mL
LYCOSA TARANTULA (UNII: 86M454L2TT) (LYCOSA TARANTULA - UNII:86M454L2TT)	LYCOSA TARANTULA	8 [hp_X] in 100 mL
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	8 [hp_X] in 100 mL
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	8 [hp_X] in 100 mL
DATURA STRAMONIUM (UNII: G6W4F0V8Z3) (DATURA STRAMONIUM - UNII:G6W4F0V8Z3)	DATURA STRAMONIUM	8 [hp_X] in 100 mL
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U)	ANAMIRTA COCCULUS SEED	8 [hp_X] in 100 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE, RASPBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60512-9064-5	1 in 1 CARTON	08/18/2008
1		100 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		08/18/2008

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(60512-9064)

DRUGS FACTS