FDA.reportPublic FDA data

Brioschi Effervescent Antacid

Manufacturer
Neobourne Pharma LP | Les Emballages Facoteck Inc
Effective date
2018-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:45

Label at a glance#

ProductBrioschi Effervescent Antacid
Active ingredientSODIUM BICARBONATE
Label structure11 sections

Indications and uses

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

Dosage and administration

Fully dissolve 5 grams (1 packet) in a 4-6 ounces of water before drinking • do not use more than directed Adults and children 12 years and older Adults 60 years and older Children under 12 One dose (1 packet) each hour One dose (1 packet) each hour Ask a doctor Do not exceed 4 doses in 24 hours Do not exceed 4 doses in 24 hours

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient (in each 5 gram dose)

OTC - ACTIVE INGREDIENT SECTION

Sodium bicarbonate (1.02 grams)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Fully dissolve 5 grams (1 packet) 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 packet) each hourOne dose (1 packet) each hourAsk a doctor
Do not exceed 4 doses in 24 hoursDo not exceed 4 doses in 24 hours

Other Information

INFORMATION FOR PATIENTS SECTION

• each 5 gram dose contains 280 mg of sodium

• store in a cool dry place

• tamper-evident unit dose packets

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lemon, malic acid, sucrose

Questions?

OTC - QUESTIONS SECTION

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 - 10 Foil Packs (5 grams each)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALL-NATURAL

Say Bree-os-kee

Brioschi.

Effervescent Antacid

For fast relief of:

Upset Stomach

Acid Indigestion

Heartburn

ASPIRIN-FREE

NDC 69276-200-05

Lemon Flavor

10 Foil Packs (5 grams each)

pdp01pdp01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1656660Brioschi 1.02 GM Granule for Oral SolutionPSN2
1656654sodium bicarbonate 1.02 GM per 5 GM Granules for Oral SolutionPSN2
1656660sodium bicarbonate 1020 MG Granules for Oral Solution [Brioschi Antacid]SBD2
1656654sodium bicarbonate 1020 MG Granules for Oral SolutionSCD2
1656660Brioschi (sodium bicarbonate 1.02 GM per 5 GM) Granules for Oral SolutionSY2
1656660Brioschi (sodium bicarbonate 1020 MG) Granules for Oral SolutionSY2
1656660Brioschi Antacid 1020 MG Granules for Oral SolutionSY2
1656654NaHCO3 1020 MG Granules for Oral SolutionSY2
1656660NaHCO3 1020 MG Granules for Oral Solution [Brioschi Antacid]SY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69276-200-052020-01-31C16284748780-19d75b9d0-14b0-f424-e053-dadaa90a57ceBrioschi Effervescent Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69276-200-05Brioschi Effervescent Antacid5 g in 1 PACKETGRANULE, EFFERVESCENT52
69276-200-05Brioschi Effervescent Antacid10 in 1 CARTONGRANULE, EFFERVESCENT102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69276-200BRIOSCHI EFFERVESCENT ANTACID (SODIUM BICARBONATE) GRANULE, EFFERVESCENT [NEOBOURNE PHARMA LP]2Legacy NDC, 2 package rows20181219_513e0139-2666-07cb-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69276-20069276-200-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB
MALIC ACID817L1N4CKPIACT
SUCROSEC151H8M554IACT
LEMON24RS0A988OIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7d507e74-f9db-bc14-e053-2a91aa0ac630513e0139-2666-07cb-e054-00144ff8d46c2018-12-18WarningsExact identifier
spl id: 7d507e74-f9db-bc14-e053-2a91aa0ac630
spl set id: 513e0139-2666-07cb-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.