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Infants Simethicone

Dosage form: solution/ drops
Ingredients: DIMETHICONE 63.3mg in 1mL, SILICON DIOXIDE 3.7mg in 1mL
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0894

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.

Infants Simethicone Drops

Active ingredient (in each 0.3 mL)

Simethicone 20 mg

Purpose

Anti-gas

Uses

Relieves the discomfort of infant 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 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 the inner cheek
  • dosage can also be mixed with 1 oz of cool water, infant formula or other suitable liquids
  • for best results, clean dropper after each use and replace original cap
AgeWeightDose
newborn - - - -0.3 mL
infants under 2 yearsunder 24 lbs0.3 mL
children over 2 yearsover 24 lbs0.6 mL

Other information
  • store at room temperature 15°- 30°C (59°- 86°F)
  • do not freeze

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

carbomer, citric acid, FD&C  red #3, flavor, hypromellose, purified water, saccharin sodium, sodium benzoate, sodium citrate

Made in the USA
for Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 6/10  R6
8276455  0894

PRINCIPAL DISPLAY PANEL
INFANTS SIMETHICONE 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0894
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE63.3 mg  in 1 mL
SILICON DIOXIDE (SILICON DIOXIDE) SILICON DIOXIDE3.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B 
ANHYDROUS CITRIC ACID 
FD&C RED NO. 3 
HYPROMELLOSES 
WATER 
SACCHARIN SODIUM 
SODIUM BENZOATE 
SODIUM CITRATE 
Packaging
#Item CodePackage Description
1NDC:0603-0894-501 BOTTLE (1 BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33210/16/1997
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE

Revised: 12/2010
Document Id: 9f5f56d8-93d2-4a08-b608-c9a28ffff2aa
Set id: ae36c885-22f2-48a6-849a-d2d89a6d24a3
Version: 3
Effective Time: 20101201
 
Qualitest Pharmaceuticals

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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