GRIPE WATER- gripe water liquid
Vitality Works

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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Maxi-Health Gripe water

Active Ingredients

(In equal parts) Chamomila 3x (Chamomile) HPUS, Mentha Piperita 3x (Peppermint) HPUS, Zingaber Officianale 3x (Ginger) HPUS, and Foeniculum Vulgare 3x (Fennel) HPUS.

Inactive Ingredients:

USP Purified Water, Vegetable Glycerin

Keep out of reach of children

Directions:

Newborn, 0.5 ml tthree times per day or as needed. 6 months, 1.0 ml three times per day or as needed.

To be used according to standard homepoathic indications

For infant relief of irritiability, hiccups, gas releif, digestive aid, bloating and colic.

Questions

info@maxihealth.com

Store tightly in a cool dry place. Keep out of reach of childre,To be used according to standard homeopathic indications.

For relief of irritability, hiccips, gas relief, digestive aid, bloating and colic

primary label

GRIPE WATER
gripe water liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64616-119
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S)	MATRICARIA CHAMOMILLA WHOLE	1 [hp_X] in 0.0025 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	1 [hp_X] in 0.0025 mL
ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) (ZINGIBER OFFICINALE WHOLE - UNII:IN6Q3S3414)	ZINGIBER OFFICINALE WHOLE	1 [hp_X] in 0.0025 mL
FOENICULUM VULGARE VAR. VULGARE WHOLE (UNII: R9S0526LYO) (FOENICULUM VULGARE VAR. VULGARE WHOLE - UNII:R9S0526LYO)	FOENICULUM VULGARE VAR. VULGARE WHOLE	1 [hp_X] in 0.0025 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64616-119-02	1 in 1 CARTON	08/29/2017
1	NDC:64616-119-01	59.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/2017

Labeler - Vitality Works (137752817)

Name	Address	ID/FEI	Business Operations
Establishment
Vitality Works, Inc.		137752817	manufacture(64616-119) , label(64616-119)