Label: BRIOSCHI EFFERVESCENT ANTACID- sodium bicarbonate granule, effervescent

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 18, 2018

If you are a consumer or patient please visit this version.

  • Drug Facts

    Drug Facts

  • Active Ingredient (in each 5 gram dose)

    Sodium bicarbonate (1.02 grams)

  • Purpose

    Antacid

  • Uses

    For the relief of heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

  • Warnings

    Do not take more than the maximum recommended daily dosage (see Directions) in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a doctor.

    Ask a doctor or pharmacist before use if you • are presently taking a prescription drug; antacids may interact with certain prescription drugs • have a sodium restricted diet

    If pregnant or breast feeding, ask a health professional before use.

    Keep this and all drugs out of reach of children.

  • Directions

    Fully dissolve 5 grams (1 scoop) in a 4-6 ounces of water before drinking • do not use more than directed

    Adults and children 12 years and olderAdults 60 years and olderChildren under 12
    One dose (1 scoop) each hourOne dose (1 scoop) each hourAsk a doctor
    Do not exceed 8 doses in 24 hoursDo not exceed 4 doses in 24 hours

  • Other Information

    • Each 5 gram dose contains 280 mg of sodium

    • Store in a cool dry place

    • Reseal cap tightly

    • Do not use if safety seal under cap is broken or missing

  • Inactive Ingredients

    lemon, malic acid, sucrose

  • Questions?

    1-844-636-2687 or info@neobourne.com

  • SPL UNCLASSIFIED SECTION

    neobourne PHARMA

    Manufactured by Les Emballages Facoteck Inc.

    35 Ch Victoria 0 Bureau 236, Scotstown, QC, Canada J0B 3B0

    for Neobourne Pharma LP. www.neobournepharma.com

    Brioschi is a registered trademark of Neobourne Pharma LP.

    All rights reserved. Visit us: www.brioschi.com

  • Principal Display Panel - Brioschi Effervescent Antacid 300g Bottle

    ALL-NATURAL

    Say Bree-os-kee

    Brioschi.

    Effervescent Antacid

    For fast relief of:

    Upset Stomach

    Acid Indigestion

    Heartburn

    Lemon Flavor

    NDC 69276-200-58

    ASPIRIN-FREE

    300 grams

    PDP-Brioschi300g

  • INGREDIENTS AND APPEARANCE
    BRIOSCHI EFFERVESCENT ANTACID 
    sodium bicarbonate granule, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69276-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1.02 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    MALIC ACID (UNII: 817L1N4CKP)  
    SUCROSE (UNII: C151H8M554)  
    LEMON (UNII: 24RS0A988O)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69276-200-58300 g in 1 BOTTLE; Type 0: Not a Combination Product11/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33111/27/2017
    Labeler - Neobourne Pharma LP (202909586)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Emballages Facoteck Inc245423439manufacture(69276-200)