FDA.reportPublic FDA data

Alka-Seltzer Heartburn Relief Lemon Lime

Manufacturer
Bayer Healthcare LLC
Effective date
2025-04-01
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:58:28

Label at a glance#

ProductAlka-Seltzer Heartburn Relief Lemon Lime
Active ingredientSODIUM BICARBONATE, CITRIC ACID MONOHYDRATE
Label structure18 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Anhydrous citric acid 1000 mg
Sodium bicarbonate (heat-treated) 1650 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 489 mg
● phenylketonurics: contains phenylalanine 4.5 mg per tablet
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Lemon Lime in water contains the antacid sodium citrate as the principal active ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredients

aspartame, flavor, magnesium stearate, mannitol

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AS_HR_LemonLime_Tablet_36Ctn_r4(002).jpgAS_HR_LemonLime_Tablet_36Ctn_r4(002).jpg​ALKA-SELTZER

Fast 4-in-1

Relief of:

Heartburn

Sour Stomach

Acid Indigestion

Upset Stomach

HEARTBURN RELIEF

LEMON LIME

36 EFFERVESCENT TABLETS

(18 - 2 count pouches)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2599360citric acid 1000 MG / sodium bicarbonate 1650 MG Effervescent Oral TabletPSN9
2599360citric acid 1000 MG / sodium bicarbonate 1650 MG Effervescent Oral TabletSCD9
2599360citric acid 1000 MG / NaHCO3 1650 MG Effervescent Oral TabletSY9

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
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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
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0083-01Alka-Seltzer Heartburn Relief Lemon Lime2 in 1 PACKETTABLET, EFFERVESCENT29
0280-0083-01Alka-Seltzer Heartburn Relief Lemon Lime18 in 1 CARTONTABLET, EFFERVESCENT189
0280-0083-02Alka-Seltzer Heartburn Relief Lemon Lime12 in 1 CARTONTABLET, EFFERVESCENT129
0280-0083-02Alka-Seltzer Heartburn Relief Lemon Lime2 in 1 PACKETTABLET, EFFERVESCENT29
0280-0083-03Alka-Seltzer Heartburn Relief Lemon Lime36 in 1 CARTONTABLET, EFFERVESCENT369
0280-0083-03Alka-Seltzer Heartburn Relief Lemon Lime2 in 1 PACKETTABLET, EFFERVESCENT29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0083ALKA-SELTZER HEARTBURN RELIEF LEMON LIME (ANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)) TABLET, EFFERVESCENT [BAYER HEALTHCARE LLC]9Current NDC, Legacy NDC, 6 package rows20250403_cc21af24-9a5b-6831-e053-2a95a90a0af4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-0083-01EA - Each0280-008345eed462-5c41-4c17-bfb3-821ce85c78e112025-01-14

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00830280-0083-01, 0280-0083-02, 0280-0083-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPARTAMEZ0H242BBR1IACT
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 Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
ndc (package): 0280-0083-03
ndc (package): 0280-0083-02
ndc (package): 0280-0083-01
ndc (product): 0280-0083
ndc11 (package): 00280008301
ndc11 (package): 00280008303
ndc11 (package): 00280008302
spl id: 31b97b49-1db4-5da9-e063-6394a90a04c3
spl set id: cc21af24-9a5b-6831-e053-2a95a90a0af4

Reported adverse events (FAERS/openFDA)#

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