FDA.reportPublic FDA data

DR. SANA BICARBONATO DE SODIO

Manufacturer
Evi Labs
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:31:42

Label at a glance#

ProductDR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 Floz
Active ingredientSODIUM BICARBONATE
Label structure12 sections

Indications and uses

For the relief of heartburn, sour stomach, acid indigestion, and upset stomach associated with this sintomas.

Dosage and administration

Adults and children 12 years of age and over. Mix 1/4 teaspoonful in water and drink. Do not use more than 4 times a day. For children under 12 years of age - ask a Doctor.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

For the relief of heartburn, sour stomach, acid indigestion, and upset stomach associated with this sintomas.

Warnings

WARNINGS SECTION

Do not take more maximum daily dosage. Do not take more than four 1/4 teaspoonfuls in 24 hour period. Do not use the maximum dosage of this product for more than 2 weeks. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if you are on a sodium restricte diet. If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Additional warning:

Stomach warning: To avoid serious injury, do not take until the powder is completely dissolved. It is very important not to take this product when overly full from food or drink. Ask the doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over. Mix 1/4 teaspoonful in water and drink.
Do not use more than 4 times a day.
For children under 12 years of age - ask a Doctor.

Other Information

OTHER SAFETY INFORMATION

Store at controlled room temperature 15-25°C (59-86 °F). This package is sold by weight, not volume. Some settings of the contents may have occurred during shipping and handling.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None.

Tamper-Evident Disclosure

WARNINGS SECTION

Do not use if the printed over-wrap over the bottle cap is torn, broken, or missing.

Questions? If you have any questions, please write Healthtx Distributor, Inc, Miami, Fl 33142.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

none

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Bicarbonate 4 ozSodium Bicarbonate 4 oz

Label-4 FL oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 4 FL ozLabel 4 FL oz

Label-6 FL oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 6 FL ozLabel 6 FL oz

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130729545308296GTIN-13: 0729545308296
EAN-13: 0729545308296
GTIN-12: 729545308296
UPC-A: 729545308296
GTIN storage (14 digits): 00729545308296		Dr. Sana Bicarbonato de Sodio 4 oz @ Mechanical label.jpg
BarcodeEAN-130729545308302GTIN-13: 0729545308302
EAN-13: 0729545308302
GTIN-12: 729545308302
UPC-A: 729545308302
GTIN storage (14 digits): 00729545308302		Dr. Sana Bicarbonato de Sodio 6 oz. @ Mechanical label (1).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84178-050-01DR. SANA BICARBONATO DE SODIO4 Fl oz and 6 Floz113 g in 1 BOTTLE, PLASTICPOWDER1132
84178-050-02DR. SANA BICARBONATO DE SODIO4 Fl oz and 6 Floz170 g in 1 BOTTLE, PLASTICPOWDER1702

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84178-05084178-050-01, 84178-050-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM BICARBONATE8MDF5V39QOACTIB

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
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
ndc (package): 84178-050-02
ndc (package): 84178-050-01
ndc (product): 84178-050
ndc11 (package): 84178005001
ndc11 (package): 84178005002
spl id: 47d0a388-8b00-abe5-e063-6294a90a239e
spl set id: 47330d09-7db1-254d-e063-6294a90ae7de

Reported adverse events (FAERS/openFDA)#

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