FDA.reportPublic FDA data

Alka-Seltzer Heartburn Relief Extra Strength

Manufacturer
Bayer Healthcare LLC
Effective date
2025-03-11
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:57:01

Label at a glance#

ProductAlka-Seltzer Heartburn Relief Extra Strength
Active ingredientSODIUM BICARBONATE, CITRIC ACID MONOHYDRATE
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Anhydrous citric acid 1000 mg

Sodium bicarbonate (heat-treated) 1976 mg

OTC - PURPOSE SECTION

Antacid

Antacid

INDICATIONS & USAGE SECTION

Uses for the relief of

  • heartburn
  • acid indigestion
  • sour stomach
  • upset stomach associated with these symptoms

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a sodium-restricted diet

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.

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

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 out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

adults and children 12 years and over2 tablets every 4 hours as needed, or as directed by a doctordo not exceed 8 tablets in 24 hours
adults 60 years and over2 tablets every 4 hours as needed, or as directed by a doctordo not exceed 4 tablets in 24 hours
children under 12 yearsconsult a doctor

OTHER SAFETY INFORMATION

Other information

● each tablet contains: sodium 586 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Extra Strength in water contains the antacid
sodium citrate as the principal active ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredients

magnesium stearate, mannitol

OTC - QUESTIONS SECTION

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​ALKA-SELTZER

Fast 4-in-1

Relief of:

Heartburn

Sour Stomach

Acid Indigestion

Upset Stomach

HEARTBURN RELIEF

EXTRA STRENGTH

24 EFFERVESCENT TABLETS

(12 - 2 count pouches)

AlkaSeltzerHRESAlkaSeltzerHRES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2571087citric acid 1000 MG / sodium bicarbonate 1976 MG Effervescent Oral TabletPSN10
2571087citric acid 1000 MG / sodium bicarbonate 1976 MG Effervescent Oral TabletSCD10
2571087citric acid 1000 MG / NaHCO3 1976 MG Effervescent Oral TabletSY10

DailyMed Pharmacologic Classes#

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

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
0280-0079-01Alka-Seltzer Heartburn Relief Extra Strength2 in 1 PACKETTABLET, EFFERVESCENT210
0280-0079-01Alka-Seltzer Heartburn Relief Extra Strength12 in 1 CARTONTABLET, EFFERVESCENT1210
0280-0079-02Alka-Seltzer Heartburn Relief Extra Strength2 in 1 PACKETTABLET, EFFERVESCENT210
0280-0079-02Alka-Seltzer Heartburn Relief Extra Strength36 in 1 CARTONTABLET, EFFERVESCENT3610
0280-0079-03Alka-Seltzer Heartburn Relief Extra Strength18 in 1 CARTONTABLET, EFFERVESCENT1810
0280-0079-03Alka-Seltzer Heartburn Relief Extra Strength2 in 1 PACKETTABLET, EFFERVESCENT210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0079ALKA-SELTZER HEARTBURN RELIEF EXTRA STRENGTH (ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC]10Current NDC, Legacy NDC, 6 package rows20250313_dc1641f8-54c2-0d86-e053-2995a90a1dce.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00790280-0079-01, 0280-0079-02, 0280-0079-03

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
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
SODIUM BICARBONATE8MDF5V39QOACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPACTIM

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
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
ndc (package): 0280-0079-01
ndc (package): 0280-0079-02
ndc (package): 0280-0079-03
ndc (product): 0280-0079
ndc11 (package): 00280007902
ndc11 (package): 00280007903
ndc11 (package): 00280007901
spl id: 30155636-9069-f8ae-e063-6394a90a54a4
spl set id: dc1641f8-54c2-0d86-e053-2995a90a1dce

Reported adverse events (FAERS/openFDA)#

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