Gripe Water by Vitality Works / Vitality Works, Inc. GRIPE WATER liquid

Gripe Water by

Drug Labeling and Warnings

Gripe Water by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Vitality Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

PURPOSE

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

Questions

info@maxihealth.com

WARNINGS

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

INDICATIONS & USAGE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GRIPE WATER 
gripe water liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/31/2017

Labeler - Vitality Works (137752817)

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