Infants Gas relief

Manufacturer
Harris Teeter, LLC
Effective date
2025-02-05
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:27

Label at a glance#

ProductInfants Gas relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

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...

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each 0.3 mL)

OTC - ACTIVE INGREDIENT SECTION

Simethicone 20 mg

PURPOSE

OTC - PURPOSE SECTION

Antigas

USE(S)

INDICATIONS & USAGE SECTION

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


WARNINGS

WARNINGS SECTION

When using this product do not exceed 12 doses per day

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

  • 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 240.3 mL
 children over 2over 240.6 mL

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at room temperature

INACTIVE INGREDIENT SECTION

benzoic acid, flavor, magnesium aluminum silicate, purified water, simethicone emulsion, sorbitol, xanthan gum.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harris Teeter™


NDC 69256-520-09



INFANTS'

GAS RELIEF DROPS

Antigas

Simethicone 20 mg

 

Fast Relief of Gas Symptoms

No Artificial Flavor

Alcohol Free

Dye Free

Gentle & Safe**


Compare to the Active Ingredient in Mylicon® 

Non-Staining Infants' Drops*


**Use only as directed;

do not exceed 12 doses per day.

1 FL OZ (30mL)


520-ht.jpg520-ht.jpg

 


DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-520-09Infants Gas relief1 in 1 CARTONSOLUTION/ DROPS12
69256-520-09Infants Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-520INFANTS GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [HARRIS TEETER, LLC]2Current NDC, 2 package rows20250207_2c39de90-4896-8a85-e063-6394a90af677.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69256-52069256-520-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 Gas reliefSIMETHICONEHarris Teeter, LLC2c39de90-4896-8a85-e063-6394a90af6772025-02-05WarningsExact identifier
ndc (package): 69256-520-09
ndc (product): 69256-520
ndc11 (package): 69256052009
spl id: f5b221f3-ed1c-4c22-ab5d-c6b846950b32
spl set id: 2c39de90-4896-8a85-e063-6394a90af677

Reported adverse events (FAERS/openFDA)#

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