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Simethicone by NuCare Pharmaceuticals,Inc.

Medically reviewed on December 29, 2017

Dosage form: suspension/ drops
Ingredients: SIMETHICONE 20mg in 0.3mL
Labeler: NuCare Pharmaceuticals,Inc.
NDC Code: 68071-4207

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.

Rugby infant drops

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Antigas

Use

relieves the symptoms referred to as gas

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 inner cheek
  • may be mixed with 1 oz of water, infant formula or other suitable liquid
  • for best results, clean dropper after each use and replace original cap
Age (years)Weight (lbs) Dose
infants (under 2)
under 24
0.3 mL
children (over 2)
over 24
0.6 mL

Other information
  • store at room temperature
  • do not freeze
  • see bottom panel for lot number and expiration date
  • TAMPER-EVIDENT: Do not use if foil seal under cap is broken or missing

Inactive ingredients

carboxymethylcellulose sodium, citric acid, flavor, maltitol, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate, xanthan gum.

Questions or comments?

1-800-645-2158

package Label

SIMETHICONE 
simethicone suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4207(NDC:0536-2220)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE20 mg  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
ANHYDROUS CITRIC ACID 
MALTITOL 
CELLULOSE, MICROCRYSTALLINE 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
XANTHAN GUM 
Product Characteristics
Colorwhite (off-white) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68071-4207-130 mL in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33212/01/2010
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIOperations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-4207)

 
NuCare Pharmaceuticals,Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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