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

INFANTS GAS AND COLIC RELIEF by

Drug Labeling and Warnings

INFANTS GAS AND COLIC RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoire Atlas 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

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

Purpose

Colocynthis (Bitter apple) 6X.......................................................................upset stomach, abdominal bloating, colic and nausea

Magnesia phosphorica (Magnesium hydrogen phosphate) 6X...........................abdominal cramps

Chamomilla (German chamomile) 6X............................................................hiccups, nausea, agitation and irritability

Dioscorea villosa (Wild yam) 6X...................................................................intestinal gas, burping and colic-like pain

Uses

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

intestinal gas

 abdominal pain

bloating & hiccups

nausea

burping

upset stomach

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

Warnings

Do not use if inner foil 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 0.75 mL orally at the onset of symptoms.

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

Age                                                                          Dose

Infants and children 0 to 9 years of age                     0.75 mL

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63388-643
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 (UNII: A1Y870209Z) (MAGNESIUM PHOSPHATE, DIBASIC - UNII:A1Y870209Z)	MAGNESIUM PHOSPHATE, DIBASIC	6 [hp_X]  in 25 mL
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	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: 63388-643-02	1 in 1 CARTON	02/19/2014
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		02/19/2014

Labeler - Laboratoire Atlas Inc (247880834)

Registrant - Laboratoire Atlas Inc (247880834)