INFANTS GAS RELIEF- simethicone suspension/ drops
MAJOR Pharmaceuticals Inc.

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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MAJOR INFANT GAS RELIEF

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Use

relieves the symptoms referred to as gas

Warnings

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

Directions

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, infant formula or other suitable liquids
clean dropper well after each use and replace original cap

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

Other information

TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing.
store at room temperature
do not freeze
see bottom panel for lot number and expiration date

Inactive ingredients

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

Questions or comments?

(800)616-2471

package Label

NDC 0904-5894-30

MAJOR
INFANTS' GAS RELIEF DROPS

Simethicone Oral Suspension USP
Anti gas
relieves the symptoms referred to as gas
dye free
plastic dropper enclosed
compare to active ingredient in MYLICON infants drops*
1 FL OZ (30 mL)

INFANTS GAS RELIEF
simethicone suspension/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0904-5894
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MALTITOL (UNII: D65DG142WK)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	white (off-white)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0904-5894-30	1 in 1 CARTON	12/01/2016
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	12/07/2010	08/01/2022

Labeler - MAJOR Pharmaceuticals Inc. (191427277)

Registrant - GCP Laboratories (965480861)

Name	Address	ID/FEI	Business Operations
Establishment
GCP Laboratories		965480861	manufacture(0904-5894)

Revised: 12/2021

Document Id: d3ad0cb3-12cb-a354-e053-2995a90abca6

Set id: b58e668f-6415-4ce0-b935-822abfd28932

Version: 4

Effective Time: 20211221

MAJOR Pharmaceuticals Inc.