PEDIACARE GAS RELIEF DROPS DYE FREE- simethicone emulsion and simethicone liquid 
Medtech Products 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 Dye Free

Drug Facts

Active ingredient

(in each 0.3 mL)

Simethicone Emulsion USP 66.7mg/Simethicone 20 mg

Purpose

Anti-Gas

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.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

Dose by weight or if weight information is not available, dose by age.

age (yr)weight (lb)dose
infants under 2under 240.3 mL
children 2 and over24 and over0.6 mL

Other information

Inactive ingredients

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

Questions or comments?

call 1-888-474-3099 Mon. – Fri. 8 am to 8 pm EST or visit us at PediaCare.com




PRINCIPAL DISPLAY PANEL

INFANTS 0-36 months
PediaCare® we care for kidsTM
Gas Relief DROPS
SIMETHICONE-ANTI GAS
NON-STAINING
1 FL OZ (30 mL)

PRINCIPAL DISPLAY PANEL
INFANTS 0-36 months
PediaCare® we care for kidsTM
Gas Relief DROPS
SIMETHICONE-ANTI GAS
NON-STAINING
1 FL OZ (30 mL)

PEDIACARE GAS RELIEF DROPS DYE FREE 
simethicone emulsion and simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-811
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-811-011 in 1 BOX
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33208/01/2011
Labeler - Medtech Products Inc. (122715688)

Revised: 4/2012
Document Id: d1a531a1-b770-45ee-a8c0-4c1b451f3dc8
Set id: af3ba224-939c-488a-96fb-fe84018031bc
Version: 2
Effective Time: 20120413
 
Medtech Products Inc.