PEDIACARE SIMETHICONE ANTIGAS- simethicone emulsion 
Strides Pharma 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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Pediacare Gas RELIEF DROPS

Drug Facts

Active ingredient

(in each 0.3 mL)

Simethicone 20 mg

(provided as simethicone emulsion 66.7 mg)

Purpose

Antigas

Uses

relieves the symptoms of 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 (1-800-222-1222) right away.

Directions

      Age(yrs)   
weight(lbs)
dose
infants
under 2
under 24
0.3mL
children 2
and over
24 and over
0.6mL

Other information

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate , sucralose, xanthan gum

Questions

1-888-474-3099 

Monday – Friday 8 am to 5 pm

Eastern standard time.

PediaCare.com

Principal Display Panel

INFANTS 0-36 months

PediaCare® 

Gas Relief DROPS

SIMETHICONE-ANTIGAS

DYE-FREE Berry Flavor

1 FL OZ (30 mL)

Carton

Carton

Label

Label

PEDIACARE SIMETHICONE ANTIGAS 
simethicone emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59556-853
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE0.011 g  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.211 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59556-853-5930 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33208/01/2011
Labeler - Strides Pharma Inc (078868278)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208MANUFACTURE(59556-853)

Revised: 9/2017
Document Id: c7e57512-6d5f-41ba-b3cb-fb9e43c2f73c
Set id: 4f7c878b-412d-4111-aa13-4c909bc1d4b4
Version: 1
Effective Time: 20170909
 
Strides Pharma Inc