INFIRST GAS RELIEF INFANTS- simethicone emulsion

iNFIRST Gas Relief by

Drug Labeling and Warnings

iNFIRST Gas Relief by is a Otc medication manufactured, distributed, or labeled by INFIRST HEALTHCARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

relieves the discomfort f infant gas frequently caused by air swallowing or certain formulas or foods

Warnings

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• ▪ shake well before using
• ▪ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• ▪ only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
• ▪ remove cap and insert syringe into the bottle
• ▪ pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (towards inner cheek).
• ▪ 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
• ▪ dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
• ▪ replace cap tightly to maintain child resistance
• ▪ mL = milliliter

Age (yr)	Weight (lb)	Dose (mL)
infants under 2	under 24	0.3
children over 2	over 24	0.6

Other information

• temper evident: do not use if printed seal under cap is broken or missing
• store between 20-25°C (68-77°F)
• do not freeze
• see bottom panel for lot number and expiration date

Inactive ingredients

Carboxymethylcellulose sodium, citric acid, D&C Red 22, D&C Red 28, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments?

1-855-848-3284 toll free (English and Spanish)

Principal Display Panel

20% MORE FREE!

62372-765-36

Infants’ MYLICON®

Simethicone -Antigas

Gas Relief

Helps a baby’s natural process of relieving gas*

ORIGINAL DROPS

Anti-Gas

PEDIATRICIAN RECOMMENDED #1 PEDIATRICIAN

Safe enough for even the newest of newborn

120 Doses

1.2 FL OZ (36 mL)

Mylicon is a registered trademark of McNeil Consumer Pharmaceuticals Co.

Important: Keep this carton for future reference on full labeling.

infirst†

HEALTHCARE

Manufactured for: Infirst Healthcare Inc. Westport, CT 06880@2018 Infirst Healthcare Inc.

#1 Brand Recommended by Pediatricians

BONUS PACK

120doses (1.2 FL OZ) for the price of 100 doses (1.0 FL OZ)

Mylicon relives gas that may cause discomfort, crying or fussiness

Visit us at Mylicon.com

* The medicine in Infants’ Mylicon gently breaks down gas bubbles, helping a baby’s natural process of expelling gas

Safe enough for even the newest of newborns*

Safe enough to use at every feeding and up to 12 times per day*

Actual bottle size

* use as directed

• No Alcohal
• No Artificial Flavor
• No Saccharin
• Gluten Free

INGREDIENTS AND APPEARANCE

INFIRST GAS RELIEF  INFANTS
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62372-765
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
D&C RED NO. 22 (UNII: 1678RKX8RT)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	PINK (pink)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62372-765-36	1 in 1 CARTON	08/05/2019
1		36 mL in 1 BOTTLE; 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	08/05/2019

Labeler - INFIRST HEALTHCARE (079159739)