FDA.reportPublic FDA data

BICARUVAS

Manufacturer
PROSANA DISTRIBUCIONES, S.A. DE C.V. | PROSANA DISTRIBUCIONES S.A. DE C.V.
Effective date
2015-09-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:38

Label at a glance#

ProductBICARUVAS
Active ingredientTARTARIC ACID, CALCIUM CARBONATE, CITRIC ACID MONOHYDRATE, SODIUM BICARBONATE
Label structure10 sections

Indications and uses

Uses for the relief of: Heartburn . Sour stomach . upset stomach associated with these symptoms

Label contents#

Full prescribing information#

Bicaruvas

STATEMENT OF IDENTITY SECTION

Double Action

BICARUVAS

.Sodium Bicarbonate

.Calcium Carbonate

Antiacid

Effervescent Powder

8 packets .17 oz (5g) ea. packet labelpacket label

Directions

DOSAGE & ADMINISTRATION SECTION

.Adult and children 12 years older dissolve one packet in 1/2 glass of water every 4 hours or as directed by your doctor.

Children under 12 years, consult a doctor

Principal Display Please see box.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal panelprincipal panel

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each packet) Purpose

Sodium Bicarbonate 2.452g antacid

Citric Acid 1.927 g antiacid

Tartaric Acid 0.220g antiacid

Calcium Carbonate .05 g antiacid

Uses

OTC - PURPOSE SECTION

Uses for the relief of:

Heartburn . Sour stomach . upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Warnings Do not exceed more than 5 packets in a 24 hour period

Do not exceed more than 3 packets in 24 hours if you are 60 years or older

the maximum dosage for more than two weeks except under the advise and supervision of a physician

Pregnant

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breat feeding, ask a helth professional before use

Overdose

OVERDOSAGE SECTION

In case of Overdose get medical help or contact a Poison Control Center right away.

Inactive

INACTIVE INGREDIENT SECTION

Inactive Ingredients

grape flavor. stevia. polyethilene glycol 4000

Other Information

INDICATIONS & USAGE SECTION

Other Information

each packet contains 671 mg of sodium

each packet contains 20 mg of calcium

store in a dry cool place

children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69728-0002-12020-01-31C16284748780-19d75b9d0-b5f9-f424-e053-dadaa90a57ceBicaruvas Double Action Antacid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69728-0002-1BICARUVAS118 mL in 1 PACKETPOWDER, FOR SOLUTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69728-0002BICARUVAS (ANTACID) POWDER, FOR SOLUTION [PROSANA DISTRIBUCIONES, S.A. DE C.V.]1Legacy NDC, 1 package rows20150922_2033ba7b-9989-24ef-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CITRIC ACID MONOHYDRATEACTIVE INGREDIENT2968PHW8QP1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO1
TARTARIC ACIDACTIVE INGREDIENTW4888I119H1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
TARTARIC ACIDACTIVE MOIETYW4888I119H1
GRAPEINACTIVE INGREDIENT6X543N684K1
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D951
STEVIA LEAFINACTIVE INGREDIENT6TC6NN08761

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69728-000269728-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TARTARIC ACIDW4888I119HACTIB
CALCIUM CARBONATEH0G9379FGKACTIM
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM
GRAPE6X543N684KIACT
STEVIA LEAF6TC6NN0876IACT
POLYETHYLENE GLYCOL 40004R4HFI6D95IACT
SODIUM BICARBONATE8MDF5V39QOACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SUPPOSITORY / RECTAL1269 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95CREAM / VAGINAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95GRANULE / ORAL83 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95CAPSULE, DELAYED RELEASE / ORAL1.28 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS24 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SOLUTION / ORAL2667 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95INJECTION / INTRAMUSCULAR3 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95OINTMENT / TOPICAL45 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95SUPPOSITORY / VAGINALNAExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET, EXTENDED RELEASE / ORAL433 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95INJECTION / INTRA-ARTICULAR3 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET, DELAYED RELEASE / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95INJECTION / INTRASYNOVIAL3 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET / SUBLINGUAL2.5 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95CAPSULE / ORAL1659 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET, COATED / ORAL2 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR375 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95OINTMENT / DENTALNAExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95TABLET / ORAL83 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 4000POLYETHYLENE GLYCOL 40004R4HFI6D95CAPSULE, EXTENDED RELEASE / ORAL10.72 mgExact identifier — unii candidate
22 equally ranked IID candidates

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
2033b69b-6a37-233c-e054-00144ff88e882033ba7b-9989-24ef-e054-00144ff8d46c2015-09-20WarningsExact identifier
spl id: 2033b69b-6a37-233c-e054-00144ff88e88
spl set id: 2033ba7b-9989-24ef-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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