FDA.reportPublic FDA data

Alka Seltzer

Manufacturer
Salimex, S.A. | Bayer de Mexico, S.A. de CV
Effective date
2012-11-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:33:40

Label at a glance#

ProductAlka Seltzer
Active ingredientASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE
Label structure9 sections

Indications and uses

heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains upset stomach with headache from overindulgence in food or drink headache, body aches, and pain alone

Dosage and administration

fully dissolve 2 tablets in 4 ounces of water before taking adults and children 12 years and over: 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours children under 12 years consult a doctor Other information each tablet contains: sodium 567 mg store at room temperat...

Label contents#

Full prescribing information#

Active Ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin 325 mg

Citric acid 1000 mg

Sodium Bicarbonate (heat treated) 1916 mg

Purpose

OTC - PURPOSE SECTION

Analgesic, Antacid

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses for the relief of:

INDICATIONS & USAGE SECTION

  • heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
  • upset stomach with headache from overindulgence in food or drink
  • headache, body aches, and pain alone

Warnings

WARNINGS SECTION

Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • asthma (wheezing)

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.

Directions

DOSAGE & ADMINISTRATION SECTION

  • fully dissolve 2 tablets in 4 ounces of water before taking
  • adults and children 12 years and over: 2 tablets every 4 hours, or as directed by a doctor do not exceed 8 tablets in 24 hours
  • adults 60 years and over 2 tablets every 4 hours, or as directed by a doctor do not exceed 4 tablets in 24 hours
  • children under 12 years consult a doctor

Other information

  • each tablet contains: sodium 567 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

INACTIVE INGREDIENT SECTION

None

Questions or comments?

OTC - QUESTIONS SECTION

1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
or www.alkaseltzer.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSN3
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN3
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBD3
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD3
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSY3
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY3
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53666-100-102021-01-29C16284748780-19855d018-d559-cd31-e053-dbdaa90ab51aAlka Seltzer
53666-403-152021-01-29C16284748780-19855d018-d559-cd31-e053-dbdaa90ab51aAlka Seltzer
53666-100-102019-11-27C16284748780-19855d018-d559-cd31-e053-dbdaa90ab51aAlka Seltzer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53666-100-10Alka Seltzer100 in 1 BOXTABLET, EFFERVESCENT1003
53666-403-15Alka Seltzer150 in 1 CASETABLET, EFFERVESCENT1503
53666-403-33Alka Seltzer12 in 1 BOXTABLET, EFFERVESCENT123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53666-100ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3Legacy NDC, 1 package rows20121114_73e85be6-1236-453b-b41c-37381a054773.zip
53666-403ALKA SELTZER (ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SALIMEX, S.A.]3Legacy NDC, 2 package rows20121114_73e85be6-1236-453b-b41c-37381a054773.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSL3
ASPIRINACTIVE INGREDIENTR16CO5Y76E3
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO3
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL3
ASPIRINACTIVE MOIETYR16CO5Y76E3
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q203

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
53666-40353666-403-33, 53666-403-15
53666-10053666-100-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
SODIUM BICARBONATE8MDF5V39QOACTIM
ASPIRINR16CO5Y76EACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
SODIUM BICARBONATE8MDF5V39QOACTIM

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
c5cec0f6-56ff-4544-a932-a133ad26c2d473e85be6-1236-453b-b41c-37381a0547732012-11-09WarningsExact identifier
spl id: c5cec0f6-56ff-4544-a932-a133ad26c2d4
spl set id: 73e85be6-1236-453b-b41c-37381a054773

Reported adverse events (FAERS/openFDA)#

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