INFANTS GAS RELIEF DROPS- simethicone emulsion 
Wal-Mart Stores,Inc.,

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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Infants’ Gas Relief Drops Simethicone/Antigas 1 FL.OZ. (30 mL)

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 sign 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 any other syringe, dropper, spoon or dosing device when giving this medicine to your child.
remove cap and insert syringe into the prescribed level.
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 (towards inner chick.

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, microcrystalline cellulose, natural flavors, polysorbate 60, potassium sorbate, purified water, sodium benzoate, sorbitan monostearate, sorbitol, xanthan gum.

Questions?

1-866-467-2748

Principal Display Panel

*Compare to active ingredient in infant’s Mylicon® Drops

Infants'

Gas Relief

Drops

Simethicone 20 mg /Antigas

 
Dye- free
 
Non-staining
 
Formula
 
No Alcohol
No Saccharin
No Artificial Colors
No Artificial Flavor

1 FL. OZ. (30 mL) 100 doses

Distributed by:

Made in USA with domestic and imported ingredients.

Factory certified.

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

 
IMPORTANT: Keep this carton for future reference on full labeling
Infant's Gas Relief Drop Simethicone Antigas

Infants Gas Relief Drops

Infants Gas Relief Drop
INFANTS GAS RELIEF DROPS 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-709
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off white, opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-709-011 in 1 CARTON10/16/2017
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49035-709-301 in 1 CARTON10/22/2019
230 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/16/2017
Labeler - Wal-Mart Stores,Inc., (051957769)

Revised: 11/2019
Document Id: 12853a6b-756a-44f3-972f-d68e2f685754
Set id: 966f0506-c2d2-4d3c-bd2d-c5a6b1e0a157
Version: 5
Effective Time: 20191106
 
Wal-Mart Stores,Inc.,