PediaCare Gas Relief Original

Dosage form: solution/ drops
Ingredients: DIMETHICONE .0211g in 1mL, SILICON DIOXIDE 0.011g in 1mL
Labeler: Medtech Products Inc.
NDC Code: 63029-800

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.

PediaCare Gas Relief Drops Original

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
  • shake well before using
  • all dosages may be repeated as needed, after meals and at bedtime
  • fill enclosed dropper to recommended dosage level

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

  • dispense liquid slowly into baby’s mouth, toward inner cheek
  • may mix with 1 oz. of cool water, infant formula or other suitable liquids
  • clean dropper after each use and replace original cap
age (yr)weight (lb)dose
infants under 2under 240.3 mL
children 2 and over24 and over0.6 mL

Other information
  • Do not freeze
  • Store at room temperature 20-25ºC (68-77ºF)
  • See bottle or box for lot number and expiration date

Inactive ingredients

citric acid, flavor, microcrystalline cellulose, propylene glycol, sodium benzoate, sodium carboxymethylcellulose, red 22, red 28, 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
1 FL OZ (30 mL)

PEDIACARE GAS RELIEF ORIGINAL 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-800
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE.0211 g  in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE0.011 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
SODIUM BENZOATE 
CARBOXYMETHYLCELLULOSE SODIUM 
D&C RED NO. 22 
D&C RED NO. 28 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63029-800-011 BOTTLE, DROPPER (1 BOTTLE) in 1 BOX
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33209/01/2010
Labeler - Medtech Products Inc. (122715688)

Revised: 04/2012
 
Medtech Products Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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