PREMIER VALUE INFANTS GAS RELIEF- simethicone emulsion 
Chain Drug Consortium

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Premier Value Infants' Drops Gas Relief Drug Facts

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. 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. Do not exceed 12 doses per day.
fill enclosed dropper to recommended dosage level and dispense liquid slowly into baby’s mouth, toward the inner cheek
dosage can also be mixed with 1 oz. cool water, infant formula or other suitable liquids
clean dropper after each use - replace bottle with 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

tamper evident: do not use if printed seal under cap is torn or missing
store at room temperature
do not freeze
see bottom panel for lot 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

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT IN INFANTS' MYLICON® DROPS*

Premier Value®

Infants'

Gas Relief

Non-Staining formula

Simethicone 20 mg/Antigas

Dye Free
No Saccharin
No Artificial Colors
No Artificial flavors

Syringe Enclosed. This Bottle contains 100 doses (0.3 mL/dose)

1 Fl. OZ (30ml)

100 Doses

Distributed by

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

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

Permier Value Infants' Gas Relief

Premier Value Infants' Gas Relief

PREMIER VALUE INFANTS GAS RELIEF 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-670
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 (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:68016-670-001 in 1 CARTON01/09/2015
130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00201/09/2015
Labeler - Chain Drug Consortium (101668460)

Revised: 11/2023
Document Id: 5534c506-4e3a-4be8-95ae-e35bbdd58c9a
Set id: 7b887e53-a70a-4f33-9472-e1175b24400a
Version: 7
Effective Time: 20231106
 
Chain Drug Consortium