GNP infant drops

Manufacturer: AMERISOURCEBERGEN DRUG CORPORATION | GCP Laboratories
Effective date: 2023-07-18
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:58:39

Label at a glance#

ProductINFANT GAS RELIEF

Active ingredientDIMETHICONE

Label structure8 sections

Dosage and administration

shake well before using all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician do not exceed 12 doses per day fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek dosage can also be mixed with 1 oz. of cool water, infan formula or other suitable liquids clean dropper well after each use and replace original cap ...

Storage and handling

store at room temperature do not freeze see bottom panel for lot number and expiration date

Contacts and useful links#

PhoneLabel contact1-800-540-3765

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves the symptoms referred to as gas

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

shake well before using
all dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician
do not exceed 12 doses per day
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward inner cheek
dosage can also be mixed with 1 oz. of cool water, infan formula or other suitable liquids
clean dropper well after each use and replace original cap on bottle

Age (years)	Weight (lbs)	Dose
infants (under 2)	under 24	0.3 mL
children (over 2)	24 and over	0.6 mL

Other information

STORAGE AND HANDLING SECTION

store at room temperature
do not freeze
see bottom panel for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198857	simethicone 20 MG in 0.3 mL Oral Suspension	PSN	4
198857	simethicone 66.7 MG/ML Oral Suspension	SCD	4
198857	simethicone 20 MG per 0.3 ML Oral Suspension	SY	4
198857	simethicone 40 MG per 0.6 ML Oral Suspension	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-547-03	INFANT GAS RELIEF	30 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	30		4
46122-547-03	INFANT GAS RELIEF	1 in 1 CARTON	SUSPENSION/ DROPS	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-547	INFANT GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [AMERISOURCEBERGEN DRUG CORPORATION]	4	Current NDC, Legacy NDC, 2 package rows	20231102_7d3c3cc6-b0a2-620d-e053-2a91aa0a159b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-547-03	ML - Milliliter	46122-547	77473185-5c29-4403-a601-f6ffb08e1131	1	2020-03-10

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

INFANT GAS RELIEF
Simethicone
CARBOXYMETHYLCELLULOSE SODIUM
ANHYDROUS CITRIC ACID
MALTITOL
CELLULOSE, MICROCRYSTALLINE
WATER
SODIUM BENZOATE
SODIUM CITRATE
XANTHAN GUM
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
46122-547	46122-547-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
MALTITOL	D65DG142WK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
XANTHAN GUM	TTV12P4NEE	IACT
DIMETHICONE	92RU3N3Y1O	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
INFANT GAS RELIEF	SIMETHICONE	AMERISOURCEBERGEN DRUG CORPORATION	7d3c3cc6-b0a2-620d-e053-2a91aa0a159b	2023-07-18	Warnings	Exact identifier ndc (package): 46122-547-03 ndc (product): 46122-547 ndc11 (package): 46122054703 spl id: 00c51ee1-d7ea-17f1-e063-6394a90ac336 spl set id: 7d3c3cc6-b0a2-620d-e053-2a91aa0a159b

Reported adverse events (FAERS/openFDA)#

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