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

Gas and Colic Kids Relief Baby by

Drug Labeling and Warnings

Gas and Colic Kids Relief Baby by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

REFERENCES

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve symptoms associated with colic*:

 intestinal gas

 abdominal pain

 bloating

 nausea

 burping

Warnings

Do not use if imprinted seal under bottle cap 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

Children under 6 months of age: Consult a licensed healthcare practitioner before using this product.

Children 6 months to 2 years old: 0.5 ml orally every 8 hours or 3 times a day.

Children 2 to 9 years old: 0.75 ml orally every 8 hours or 3 times a day.

Other information

Store at room temperature.

Inactive Ingredients

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

CARTON

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-9200
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	6 [hp_X]  in 25 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	6 [hp_X]  in 25 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	6 [hp_X]  in 25 mL
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA ROOT	6 [hp_X]  in 25 mL

Inactive Ingredients
Ingredient Name	Strength
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	RASPBERRY, GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-9200-8	1 in 1 BOX	08/16/2016
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/16/2016

Labeler - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(60512-9200)