SIMETHICONE 125 MG- simethicone tablet, chewable 
ATLANTIC BIOLOGICALS CORP.

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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Simethicone 125 mg

Drug Facts

Active ingredient (in each chewable tablet)

Simethicone 125 mg

Antiflatulent

Use

relieves bloating, pressure and fullness commonly referred to as gas

Warnings

Keep out of reach of children

Keep out of reach of children

Directions

Other information

store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

compressible sugar, dextrose, maltodextrin, microcrystaline cellulose, peppermint flavor, silicon dioxide, sorbitol, stearic acid

Questions or comments?

call 516-341-0666, 8:30 am -4:30 pm ET, Monday - Friday

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Mylanta®

Distributed by:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

NDC 17856-0137-01

Simethicone 125 mg

ANTIFLATULENT

100ct CHEWABLE TABLETS

image description

SIMETHICONE 125 MG 
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0137(NDC:69618-032)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PEPPERMINT (UNII: V95R5KMY2B)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DEXTROSE (UNII: IY9XDZ35W2)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorwhite (Off white) Score2 pieces
ShapeROUNDSize16mm
FlavorImprint Code AP;040
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0137-1100 in 1 BOX, UNIT-DOSE09/29/2022
1NDC:17856-0137-21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/25/2018
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
UNIT DOSE SOLUTIONS360804194repack(17856-0137)

Revised: 9/2022
Document Id: af4e13a0-49fd-4a8e-98c8-64f53299da5c
Set id: 4ce98db3-c7a6-4627-88c5-9de302a53188
Version: 2
Effective Time: 20220929
 
ATLANTIC BIOLOGICALS CORP.