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Maximum Strength Gas Relief by PuraCap Pharmaceutical LLC

Medically reviewed on November 22, 2017

Dosage form: capsule, liquid filled
Ingredients: SIMETHICONE 250mg
Labeler: PuraCap Pharmaceutical LLC
NDC Code: 51013-424

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 toll free: 1-800-719-9260

PRINCIPAL DISPLAY PANEL

MB MAXIMUM STRENGTH Gas Relief

SIMETHICONE 250 mg    24 SOFTGELS

NDC 51013-424-04

Compare to PHAZYME® Maximum Strength active ingredient*

MAXIMUM STRENGTH GAS RELIEF 
simethicone capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51013-424
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:51013-424-042 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 finalpart33211/22/2017
Labeler - PuraCap Pharmaceutical LLC (962106329)
Establishment
NameAddressID/FEIOperations
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.421293287manufacture(51013-424), analysis(51013-424)

 
PuraCap Pharmaceutical LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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