PediaCare Infants Gas Relief

Dosage form: liquid
Ingredients: DIMETHICONE 6.3mg in 1mL, SILICON DIOXIDE 0.37mg in 1mL
Labeler: Blacksmith Brands, Inc.
NDC Code: 52183-363

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 Infants Gas Relief Drops

Drug Facts

Active ingredient

(in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

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 this and all drugs out of the 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
  • fill enclosed dropper to recommended dosage level
  • dispense liquid slowly into baby’s mouth, toward the 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 overover 240.6 mL

Other information

store at room temperature (59°F - 86°F)

Inactive ingredients

benzoic acid, D&C Red 22, D&C Red 28, magnesium aluminum silicate, natural flavor, purified water, sorbitol, xanthan gum.

Questions or comments?

call 1-888-474-3099

PRINCIPAL DISPLAY PANEL

New PediaCare® Infants
Gas Relief Drops
1 FL OZ (30 mL)

PEDIACARE INFANTS GAS RELIEF 
simethicone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52183-363
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE6.3 mg  in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE0.37 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
D&C RED NO. 28 
MAGNESIUM ALUMINUM SILICATE 
WATER 
SORBITOL 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:52183-363-011 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33210/12/2010
Labeler - Blacksmith Brands, Inc. (021411299)
Establishment
NameAddressID/FEIOperations
Guardian Drug Company119210276MANUFACTURE

Revised: 10/2010
 
Blacksmith Brands, 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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