GAS RELIEF MINT FLAVOR- simethicone tablet, chewable 
Raritan Pharmaceuticals 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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DRxCHOICE Simethicone Gas Relief 36 Chewable Tablets

Active ingredient (in each tablet)

Simethicone 80 mg

Purpose

Antigas

Uses

Relieves:

bloating
pressure
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 immediately at 1-800-222-1222.

Directions

thoroughly chew 1 to 2 tablets as needed after meals and at bedtime
do not exceed 4 tablets in 24 hours period except under the advice and supervision of a physician.

Other information

store at room temperature 20-25ºC (68-77ºF)
each tablets contains: calcium 60mg

Inactive ingredients

dextrose, peppermint flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, silica, tribasic calcium phosphate

Principal Display Panel

NDC 68163-111-36

DRx CHOICE

Gas Relief

Anti Gas/Simethicone 80 mg

For fast relief of Bloating, Pressure & Gas Distress

Mint Flavor

Naturally and Artificially Flavored

36 CHEWABLE TABLETS

Manufactured by: Raritan Pharmaceuticals

8 Joanna Court, East Brunswick, NJ 08816

DRx Choice Simethicone 36 Chewable Tablets

Simethicone 36 Chewable Tablets

GAS RELIEF  MINT FLAVOR
simethicone tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-111
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE80 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
PEPPERMINT (UNII: V95R5KMY2B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize13mm
FlavorPEPPERMINTImprint Code RP111
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-111-3636 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/17/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33204/17/2019
Labeler - Raritan Pharmaceuticals Inc (127602287)

Revised: 9/2023
Document Id: 7acae853-642c-4bc4-ad63-f82f332334dc
Set id: 329388cb-3ca1-4ecb-8b50-b1f9e0052559
Version: 5
Effective Time: 20230901
 
Raritan Pharmaceuticals Inc