PUBLIX INFANTS DYE FREE GAS RELIEF- simethicone emulsion

Publix Infants Dye Free by

Drug Labeling and Warnings

Publix Infants Dye Free by is a Otc medication manufactured, distributed, or labeled by PUBLIX SUPER MARKETS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Uses

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

Warnings

Keep out of reach of children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• shake well before using
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• only use the enclosed syringe. Do not use other syringe, dropper, spoon or dosing device when giving this medicine to your child.
• remove cap and insert syringe into the bottle
• pull syringe up until filled to the prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child’s mouth (toward inner cheek).
• all dosages may be repeated as needed, after meals and at bedtime or as directed by a physician.
• do not exceed 12 doses per day.
• dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
• replace cap tightly to maintain child resistance
• mL = milliliter

Age (yr)	Weight (lb)	Dose (mL)
infants under 2	under 24	0.3
children over 2	over 24	0.6

Other information

• tamper evident: do not use if printed seal under cap is broken or missing
• store at room temperature
• do not freeze
• see bottom panel for lot number and expiration date

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavors, microcrystalline cellulose, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum

Questions or comments ?

Call 1-866-467-2748

Principal Display Panel

NDC# 41415-709-01

Publix®

*Compare to the Active Ingredient in Infants’ Mylicon® Drops

INFANTS’ GAS RELIEF

DYE-FREE DROPS

SIMETHICONE ANTIGAS 20 MG/Antigas

• No alcohol
• No Saccharin
• No Artificial Colors & Flavor
• Non-Staining formula

1 Fl. OZ (30ml)

Syringe Enclosed.

This bottle contains 100 doses (0.3 mL/dose)

IMPORTANT: Keep this carton for future reference on full labeling

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

1-888-267-3037 publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION OR YOUR MONEY BACK

*This product is not manufactured or distributed by Infirst Healthcare Inc., the distributor of Infants’ Mylicon® Drops.

INGREDIENTS AND APPEARANCE

PUBLIX INFANTS DYE FREE  GAS RELIEF
simethicone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-709
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41415-709-01	1 in 1 CARTON	05/17/2019
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 final	part332	05/17/2019

Labeler - PUBLIX SUPER MARKETS, INC (006922009)