Infants Simethicone Drops

Manufacturer
PAI Holdings, LLC dba PAI Pharma
Effective date
2026-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:22

Label at a glance#

ProductInfants Simethicone Drops
Active ingredientDIMETHICONE
Label structure10 sections

Dosage and administration

dose may be repeated as needed, after meals and at bedtime, or as directed by a physician only use the unit dose filled syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to a child do not exceed 12 doses per day dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids discard syringe after use mL = milliliter Age (years)   Weight (lbs)  ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 0.3 mL filled syringe)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

Purpose

OTC - PURPOSE SECTION

Antigas

Use

INDICATIONS & USAGE SECTION

relieves the symptoms referred to as gas

Warnings

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dose may be repeated as needed, after meals and at bedtime, or as directed by a physician
  • only use the unit dose filled syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to a child
  • do not exceed 12 doses per day
  • dosage can also be mixed with 1 oz. of cool water, infant formula or other suitable liquids
  • discard syringe after use
  • mL = milliliter
Age (years) Weight (lbs) Dose 
 infants (under 2)  under 24 0.3 mL

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 15º-30ºC (59º-86ºF)
  • protect from freezing
  • do not use if wrapper containing syringe is torn or open

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-845-8210

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0121-1094-03

Compare to the 
ingredient of
infants MYLICON®*

Infants'
Simethicone Drops

DYE FREE

20 mg/0.3 mL

Antigas

Relieves the Symptoms
Referred to as Gas

PAI Pharma

 

Each Box Contains
25 x 0.3 mL (0.01010 fl oz) Unit Dose Filled Syringes

 

carton for Infants Simethicone Dropscarton for Infants Simethicone Drops

 

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0121-10940121-1094-01, 0121-1094-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
Infants Simethicone DropsINFANTS SIMETHICONE DROPSPAI Holdings, LLC dba PAI Pharma235f458e-c275-4bc1-9c0f-e007c40406492026-06-03WarningsExact identifier
ndc (package): 0121-1094-03
ndc (package): 0121-1094-01
ndc (product): 0121-1094
ndc11 (package): 00121109401
ndc11 (package): 00121109403
spl id: b858c7a8-bd06-4880-8c83-7c3a84f59592
spl set id: 235f458e-c275-4bc1-9c0f-e007c4040649

Reported adverse events (FAERS/openFDA)#

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