HEB Infants Gas Relief Drops

Manufacturer
H E B | Guardian Drug Company
Effective date
2023-12-04
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:16

Key Label Information#

Active Ingredients And Purpose

ACTIVE INGREDIENT (in each 0.3 mL)

Simethicone 20 mg

PURPOSE

Antigas

Uses

USE(S)

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

Warnings

WARNINGS

When using this product do not exceed 12 doses per day

Directions And Dosage

DIRECTIONS

shake well before using all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician. 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 mL children over 2 over 24 0.6 mL

Other Label Information

OTHER INFORMATION

store at room temperature

INACTIVE INGREDIENT SECTION

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

QUESTIONS?

You may report serious side effects to 1-609-860-2600 (Monday-Friday 8 am-4 pm EST).

PRINCIPAL DISPLAY PANEL

Compare to Infants' Mylicon ® Drops Non-Staining active ingredient* NDC 37808-014-09 HEB Infants' Non-Staining Gas Relief Drops simethicone 20 mg Anti-Gas Fast Relief of Gas Symptoms No Artificial flavor Gentle & Safe** Alcohol Free Dye free **Use only as directed, do not exceed more than 12 doses per day. 1 FL OZ (30 mL)

Label Images#

520-heb
520-heb

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-014-09Infants Non-staining Gas relief1 in 1 CARTONSOLUTION/ DROPS12
37808-014-09Infants Non-staining Gas relief30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-014INFANTS NON-STAINING GAS RELIEF (SIMETHICONE) SOLUTION/ DROPS [H E B]2Current NDC, Legacy NDC, 2 package rows20231205_99d94de2-9550-4d2d-99d4-1be0ef7b7880.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-01437808-014-09

Ingredients#

Complete SPL Sections#

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 or as directed by a physician. 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 mL children over 2 over 24 0.6 mL

OTHER INFORMATION

STORAGE AND HANDLING SECTION

store at room temperature

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

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

QUESTIONS?

OTC - QUESTIONS SECTION

You may report serious side effects to 1-609-860-2600 (Monday-Friday 8 am-4 pm EST).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Infants' Mylicon ® Drops Non-Staining active ingredient* NDC 37808-014-09 HEB Infants' Non-Staining Gas Relief Drops simethicone 20 mg Anti-Gas Fast Relief of Gas Symptoms No Artificial flavor Gentle & Safe** Alcohol Free Dye free **Use only as directed, do not exceed more than 12 doses per day. 1 FL OZ (30 mL)

Source Document#

Source XML