Active Ingredients HPUS:

Asafoetida (Asafetida) 8X

Ignatia amara (Ignatius bean) 8X

Valeriana officinalis (Valerian) 8X

Avena sativa (Oats) 8X

Argentum nitricum (Silver nitrate) 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

Anguish and fear

Apprehension, anxiety and irritability

Nightmares and nervousness

Lack of concentration

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic 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 of:

• restlessness

• nervousness

• irritability

• agitation

• sleeplessness

• lessens nightmares

Warnings

Stop use and ask a doctor if symptoms worsen.

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 is broken or missing.

Inactive Ingredients

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

CARTON

image of carton

LABEL

image of label

WITH CALMING EFFECT KIDS RELIEF
asafoetida, ignatia amara, valeriana officinalis, avena sativa, argentum nitricum, hyoscyamus niger, paeonia officinalis, stramonium, cocculus indicus syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60512-9164
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
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	Marketing End Date
Packaging
1	NDC:60512-9164-5	100 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/07/2013

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(60512-9164)

DRUGS FACTS