INFANTS NON-STAINING GAS RELIEF- simethicone solution/ drops

Infants Non-staining Gas relief by

Drug Labeling and Warnings

Infants Non-staining Gas relief by is a Otc medication manufactured, distributed, or labeled by H E B, Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT (in each 0.3 mL)

Simethicone 20 mg

PURPOSE

Antigas

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

KEEP OUT OF REACH OF CHILDREN

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

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 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)

 

INGREDIENTS AND APPEARANCE

INFANTS NON-STAINING GAS RELIEF 
simethicone solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 0.3 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-014-09	1 in 1 CARTON	11/15/2021
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	part332	11/15/2021

Labeler - H E B (007924756)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(37808-014)