Gripe Water

Manufacturer: Vitality Works | Vitality Works, Inc.
Effective date: 2025-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 02:36:07

Label at a glance#

ProductGripe Water

Active ingredientMATRICARIA CHAMOMILLA WHOLE, MENTHA PIPERITA, ZINGIBER OFFICINALE WHOLE, FOENICULUM VULGARE VAR. VULGARE WHOLE

Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

(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:

INACTIVE INGREDIENT SECTION

USP Purified Water, Vegetable Glycerin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

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

Questions

OTC - QUESTIONS SECTION

info@maxihealth.com

WARNINGS SECTION

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

INDICATIONS & USAGE SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

primary label

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0753406367023	GTIN-13: 0753406367023 EAN-13: 0753406367023 GTIN-12: 753406367023 UPC-A: 753406367023 GTIN storage (14 digits): 00753406367023	gripe water label.jpg
QR code link	QR Code	www.maxihealth.com/		gripe water label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64616-119-01	Gripe Water	59.1 mL in 1 BOTTLE, DROPPER	LIQUID	59.1		7
64616-119-02	Gripe Water	1 in 1 CARTON	LIQUID	1		7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

Gripe Water
GLYCERIN
WATER
MATRICARIA CHAMOMILLA WHOLE
MENTHA PIPERITA
ZINGIBER OFFICINALE WHOLE
FOENICULUM VULGARE VAR. VULGARE WHOLE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64616-119	64616-119-01, 64616-119-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
MATRICARIA CHAMOMILLA WHOLE	2Z4LRR776S	ACTIB
MENTHA PIPERITA	79M2M2UDA9	ACTIB
ZINGIBER OFFICINALE WHOLE	IN6Q3S3414	ACTIB
FOENICULUM VULGARE VAR. VULGARE WHOLE	R9S0526LYO	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gripe Water	GRIPE WATER	Vitality Works	45ade734-f446-4370-e054-00144ff88e88	2025-12-17	Warnings	Exact identifier ndc (package): 64616-119-02 ndc (package): 64616-119-01 ndc (product): 64616-119 ndc11 (package): 64616011901 ndc11 (package): 64616011902 spl id: 462f6fc3-ff7b-4849-e063-6294a90a28f9 spl set id: 45ade734-f446-4370-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.