SIMETHICONE - simethicone solution/ drops 
Physicians Total Care, Inc.

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.

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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

AgeWeightDose
newborn - - - -0.3 mL
infants under 2 yearsunder 24 lbs0.3 mL
children over 2 yearsover 24 lbs0.6 mL

Other information

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

image of package label
SIMETHICONE 
simethicone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-5620(NDC:0603-0894)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE63.3 mg  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE3.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5620-01 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/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 5/2012
Document Id: 573b81a1-0a14-49d6-98a7-bb99be916201
Set id: 6a3055bf-74ac-429b-b510-4f668f667685
Version: 1
Effective Time: 20120502
 
Physicians Total Care, Inc.