L-Oral GAS RELIEF Drops

L-Oral Gas RELIEF DROPS by

Drug Labeling and Warnings

L-Oral Gas RELIEF DROPS by is a Otc medication manufactured, distributed, or labeled by GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

L-ORAL GAS RELIEF DROPS- simethicone solution/ drops 
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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L-Oral GAS RELIEF Drops

DRUG FACTS

ACTIVE INGREDIENT (IN EACH 0.3 ML)

Simethicone 20 mg

PURPOSE

Anti-flatulence

USES

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

WARNINGS

When using this product Do not exceed 12 doses per day

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

DIRECTIONS

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

Store at room temperature

INACTIVE INGREDIENTS

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

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

L-ORAL GAS RELIEF DROPS 
simethicone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73921-025
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73921-025-15	1 in 1 CARTON	04/01/2021	02/08/2023
1		15 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
OTC monograph final	part332	04/01/2021	02/08/2023

Labeler - GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED (860186917)

Establishment
Name	Address	ID/FEI	Business Operations
GLOBAL PHARMA HEALTHCARE PRIVATE LIMITED		860186917	manufacture(73921-025)

Revised: 2/2023

Document Id: f42c0ca9-25aa-5c50-e053-2995a90ab2c5

34390-5

Set id: 243b5254-d5a7-4208-8aac-9c7354dd1231

Version: 2

Effective Time: 20230208