iNFIRST Gas Relief Infants’ Drops Drug Facts

Manufacturer
INFIRST HEALTHCARE
Effective date
2019-09-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:12:34

Label at a glance#

ProductiNFIRST Gas Relief Infants
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

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

Dosage and administration

▪ 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...

Storage and handling

• 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

Label contents#

Full prescribing information#

Active ingredient (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.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
765ORG36MYLFC INFANTS MYLICON SIMETHICONE
765ORG36MYLFC INFANTS MYLICON SIMETHICONE

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130819903010494GTIN-13: 0819903010494
EAN-13: 0819903010494
GTIN-12: 819903010494
UPC-A: 819903010494
GTIN storage (14 digits): 00819903010494
882 1J infants gas relief image.jpg

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62372-76562372-765-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c441a11-2c21-c0ef-e063-6294a90abc86a8ab5cdc-a2f2-4a1b-9b88-bc77de1f978d2023-12-11WarningsExact identifier
spl set id: a8ab5cdc-a2f2-4a1b-9b88-bc77de1f978d

Reported adverse events (FAERS/openFDA)#

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