Heb Infants Gas Relief Drops

Heb Infants Gas Relief Drops
SPL v2
SPL
SPL Set ID 99d94de2-9550-4d2d-99d4-1be0ef7b7880
Route
ORAL
Published
Effective Date 2023-12-04
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg)
Inactive Ingredients
Benzoic Acid Magnesium Aluminum Silicate Water Sorbitol Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-15

Description

Simethicone 20 mg

Purpose

Antigas


Medication Information

Purpose

Antigas

Description

Simethicone 20 mg

Use(s)

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



Warnings

When using this product do not exceed 12 doses per day

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


Questions?

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

Other Information

store at room temperature

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)

 

Inactive Ingredient Section

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

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 0.3 Ml)

Simethicone 20 mg


Structured Label Content

Use(s) (USE(S))

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



Purpose (PURPOSE)

Antigas

Warnings (WARNINGS)

When using this product do not exceed 12 doses per day

Directions (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


Questions? (QUESTIONS?)

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

Other Information (OTHER INFORMATION)

store at room temperature

Principal Display Panel (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)

 

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each 0.3 Ml) (ACTIVE INGREDIENT (in each 0.3 mL))

Simethicone 20 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)