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Simethicone by Physicians Total Care, Inc.

Dosage form: solution/ drops
Ingredients: SIMETHICONE 63.3mg in 1mL, SILICON DIOXIDE 3.7mg in 1mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-5620

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



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

PRINCIPAL DISPLAY PANEL
SIMETHICONE 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5620(NDC:0603-0894)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE63.3 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:54868-5620-01 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 FINALpart33210/30/2007
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

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Medically reviewed on May 2, 2018

Further information

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

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