HEALTHY ACCENTS GAS RELIEF- dimethicone emulsion
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DZA Brands, LLC Gas Relief Drug Facts

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

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.

Directions

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 replace original cap

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 (59°-86°F)

Inactive ingredients

citric acid, flavor, hypromellose, maltitol, methylcellulose, mono- and di- glycerides, polyethylene glycol, polyethylene glycol stearate, polysorbate 65, purified water, sodium benzoate, sodium citrate, sorbic acid, xanthan gum

Questions or comments?

1-866-322-2439

Principal Display Panel

infants’

gas relief

simethicone, 20mg

anti-gas drops

no saccharin

no artificial flavor

no artificial colors

non-staining

Compare to Infants' Mylicon® Drops active ingredient

100 doses

DROPPER ENCLOSED

alcohol free

Gas Relief Carton Image 1

Gas Relief Carton Image 2

HEALTHY ACCENTS GAS RELIEF
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:55316-882
Route of Administration	ORAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIMETHICONE (DIMETHICONE)	DIMETHICONE	20 mg in 0.3 mL

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE
CITRIC ACID MONOHYDRATE
HYPROMELLOSES
MALTITOL
POLYETHYLENE GLYCOLS
GLYCOL STEARATE
WATER
SODIUM BENZOATE
SODIUM CITRATE
SORBIC ACID
XANTHAN GUM

Product Characteristics
Color	WHITE (white to off white, opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:55316-882-10	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part332	02/24/2008

Labeler - DZA Brands LLC (090322194)

Revised: 11/2011

Document Id: 6688b708-606e-490f-a69b-0e3cb83119fa

Set id: 6688b708-606e-490f-a69b-0e3cb83119fa

Version: 1

Effective Time: 20111121

DZA Brands LLC