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Maximum Strength Gas Relief by FOODHOLD U.S.A., LLC

Medically reviewed on October 5, 2016

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 250mg
Labeler: FOODHOLD U.S.A., LLC
NDC Code: 41520-983

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.

MAXIMUM STRENGTH GAS RELIEF

Active ingredient (in each softgel)

Simethicone 250 mg

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 after a meal
  • do not exceed two softgels per 24 hours except under the advice and supervision of a physician

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

Inactive ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, purified water, and white edible ink

Questions or comments?

Call: 1-855-215-8180

PRINCIPAL DISPLAY PANEL

CAREONE MAXIMUM STRENGTH GAS RELIEF

SIMETHICONE 250 mg

Anti-gas

NDC 41520-983-02

Compare to the active ingredient in PHAZYME® Maximum Strength

12 Liquid-Filled SoftGels

MAXIMUM STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-983
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SIMETHICONE (SIMETHICONE) SIMETHICONE250 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
WATER 
Product Characteristics
Colorpurple (clear) Scoreno score
Shapecapsule (oval) Size13mm
FlavorImprint CodePC31
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-983-021 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33210/05/2016
Labeler - FOODHOLD U.S.A., LLC (809183973)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(41520-983), analysis(41520-983)

 
FOODHOLD U.S.A., LLC

← See all Maximum Strength Gas Relief brands

Further information

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

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