GAS AND COLIC KIDS RELIEF - citrullus colocynthis fruit pulp, magnesium phosphate, dibasic trihydrate, matricaria recutita and dioscorea villosa root liquid
HOMEOLAB USA INC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS

ACTIVE INGREDIENTS HPUS

Colocynthis (Bitter apple) 6X

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X

Chamomilla (German chamomile) 6X

Dioscorea villosa (Wild yam) 6X

PURPOSE

Abdominal bloating, colic and nausea.
Abdominal cramps.
Nausea, agitation and irritability.
Intestinal gas, burping and colic-like pain.

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

USES

This homeopathic medicine helps relieve symptoms associated with colic:

- intestinal gas

- abdominal pain

- bloating

- nausea

- burping.

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 2 days.

Keep out of reach of children.

DIRECTIONS

Do not use more than directed.

Take .75 ml orally at the onset of symptoms.

Repeat every 15 minutes up to 4 times then reduce with improvement or as directed by a healthcare professional.

Infants and children 0 to 9 years of age: .75 ml

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

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

CARTON

image of carton label

LABEL

image of bottle label

GAS AND COLIC KIDS RELIEF
colocynthis, magnesia phosphorica, chamomilla, dioscorea villosa liquid

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:60512-9083
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP)	CITRULLUS COLOCYNTHIS FRUIT PULP	6 [hp_X] in 25 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	6 [hp_X] in 25 mL
MATRICARIA RECUTITA (MATRICARIA RECUTITA)	MATRICARIA RECUTITA	6 [hp_X] in 25 mL
DIOSCOREA VILLOSA ROOT (DIOSCOREA VILLOSA ROOT)	DIOSCOREA VILLOSA ROOT	6 [hp_X] in 25 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
SORBITOL
SODIUM BENZOATE
POTASSIUM SORBATE
CITRIC ACID MONOHYDRATE

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

#	Item Code	Package Description
Packaging
1	NDC:60512-9083-8	1 in 1 CARTON
1		25 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/22/2011

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture

Revised: 11/2011

Document Id: 49c55573-d02b-43e2-bbc2-86131be1d221

Set id: 7268793e-e3e5-4e3c-bed2-0531e1b91b20

Version: 2

Effective Time: 20111104

HOMEOLAB USA INC