PHAZYME- simethicone capsule, gelatin coated 
Medtech Products 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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Phazyme Anti-Gas

Drug Facts

Active ingredient

(in each softgel)

Simethicone 180mg

Purpose

Anti-gas

Use

  • relieves bloating, pressure or fullness commonly referred to as gas

Warnings

Stop use and ask a doctor if

condition persists

Keep out of reach of children.

Directions

  • swallow one or two softgels as needed after a meal
  • do not exceed two softgels per day except under the advice and supervision of a physician

Other information

  • store at room temperature 59º - 86ºF (15º - 30ºC)

Inactive ingredients

FD&C yellow no. 6, gelatin, glycerin, white edible ink

Questions?

call toll-free 1-866-255-5204 (English/Spanish) weekdays

PRINCIPAL DISPLAY PANEL

180mg ULTRA STRENGTH STRONGEST DOSE AVAILABLE!
PhaZyme ANTI-GAS/SIMETHICONE 180mg
100 SOFTGELS (180mg)
Easy to Swallow

PRINCIPAL DISPLAY PANEL 180mg ULTRA STRENGTH STRONGEST DOSE AVAILABLE! PhaZyme ANTI-GAS/SIMETHICONE 180mg 100 SOFTGELS (180mg) Easy to Swallow

PHAZYME 
simethicone capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-550
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE 410 (UNII: TYU5GP6XGE) (DIMETHICONE 410 - UNII:TYU5GP6XGE) DIMETHICONE 410180 mg
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code PZ;180
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-550-011 in 1 BOX06/01/201206/30/2020
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:63029-550-021 in 1 BOX06/01/201206/30/2020
212 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:63029-550-361 in 1 BOX06/01/201206/30/2020
336 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:63029-550-601 in 1 BOX06/01/201206/30/2020
460 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33206/01/201206/30/2020
Labeler - Medtech Products Inc. (122715688)

Revised: 7/2020
Document Id: 1b45f8a8-99bb-430d-b49e-2f7dbccdd379
Set id: 733b328b-609c-4586-a7a1-06302f806cd0
Version: 3
Effective Time: 20200702
 
Medtech Products Inc.