Label at a glance#

ProductL-Oral Gas RELIEF DROPS

Active ingredientDIMETHICONE

Label structure9 sections

Indications and uses

Relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

Dosage and administration

• Shake well before using • All dosages may be repeated as needed, after meals and at bedtime • Fill enclosed dropper to recommended dosage level • Dispense liquid slowly into baby's mouth, toward the inner cheek • May mix with 1 oz. of cool water, infant formula or other suitable liquids • Clean dropper after each use and close the bottle to maintain child resistance Age (yr) Weight (lb) Dose Infants under 2 ...

Storage and handling

Store at room temperature

Contacts and useful links#

Websitewww.global-pharma.com

www.global-pharma.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH 0.3 ML)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

PURPOSE

OTC - PURPOSE SECTION

Anti-flatulence

USES

INDICATIONS & USAGE SECTION

Relieves the symptoms of gas frequently caused by air swallowing or certain formulas or foods

WARNINGS

WARNINGS SECTION

When using this product Do not exceed 12 doses per day

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 immediately.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Shake well before using • All dosages may be repeated as needed, after meals and at bedtime • Fill enclosed dropper to recommended dosage level • Dispense liquid slowly into baby's mouth, toward the inner cheek • May mix with 1 oz. of cool water, infant formula or other suitable liquids • Clean dropper after each use and close the bottle to maintain child resistance


Age (yr)	Weight (lb)	Dose
Infants under 2	Under 24	0.3 mL
Children over 2	Over 24	0.6 mL

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Benzoic acid, Flavor, Magnesium aluminum silicate, Purified water, Simethicone emulsion, Sorbitol, Xanthan gum

SPL UNCLASSIFIED SECTION

INFANTS

•Relieves stomach discomfort from excess gas
• Alcohol free • Saccharin free
• No artificial flavors • Non staining formula

Manufactured by :

Global Pharma Healthcare Pvt. Ltd.,

A-9, SIDCO Pharmaceutical Complex,

Alathur-603 110 - INDIA.

www.global-pharma.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Grelief1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73921-025-15	2023-02-08	C162847	48780-1	f386c649-d5c1-0266-e053-dadaa90a7c1a	L-Oral GAS RELIEF Drops
73921-025-15	2023-01-30	C162847	48780-1	f386c649-d5c1-0266-e053-dadaa90a7c1a	L-Oral GAS RELIEF Drops

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

L-Oral Gas RELIEF DROPS
Simethicone
DIMETHICONE
BENZOIC ACID
MAGNESIUM ALUMINUM SILICATE
WATER
SILICON DIOXIDE
SORBITOL
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73921-025	73921-025-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	ACTIB
BENZOIC ACID	8SKN0B0MIM	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
WATER	059QF0KO0R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SORBITOL	506T60A25R	IACT
XANTHAN GUM	TTV12P4NEE	IACT

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
f42c0ca9-25aa-5c50-e053-2995a90ab2c5			243b5254-d5a7-4208-8aac-9c7354dd1231	2023-02-08	Warnings	Exact identifier spl set id: 243b5254-d5a7-4208-8aac-9c7354dd1231

Reported adverse events (FAERS/openFDA)#

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