FDA.reportPublic FDA data

Alka-Seltzer Original

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:19:51

Label at a glance#

ProductAlka-Seltzer Original
Active ingredientANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE
Label structure10 sections

Indications and uses

for the temporary relief of: 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

Directions ● 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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Anhydrous citric acid 1000 mgAntacid
Aspirin 325 mg (NSAID) * Analgesic
Sodium bicarbonate (heat-treated) 1916 mgAntacid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of:

  • 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

SPL UNCLASSIFIED SECTION

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma
  • you have a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • taking a prescription drug for diabetes, gout, or arthritis

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • symptoms get worse or last more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
  • new symptoms occur

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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

Other information

STORAGE AND HANDLING SECTION

  • 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)

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC
Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 24 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer ®

Anhydrous citric acid / Antacid

Aspirin ( NSAID) / Analgesic

Sodium bicarbonate / Antacid

Fast Relief of:

Heartburn

Upset Stomach

Acid Indigestion

with Headache

Body Aches

ORIGINAL

24 EFFERVESCENT TABLETS

originaloriginal

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSN11
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN11
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBD11
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD11
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSY11
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY11
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SY11

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-4000-01Alka-Seltzer Original6 in 1 CARTONTABLET, EFFERVESCENT611
0280-4000-01Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211
0280-4000-02Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211
0280-4000-02Alka-Seltzer Original24 in 1 CARTONTABLET, EFFERVESCENT2411
0280-4000-03Alka-Seltzer Original18 in 1 CARTONTABLET, EFFERVESCENT1811
0280-4000-03Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211
0280-4000-04Alka-Seltzer Original58 in 1 CARTONTABLET, EFFERVESCENT5811
0280-4000-04Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211
0280-4000-05Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211
0280-4000-05Alka-Seltzer Original36 in 1 CARTONTABLET, EFFERVESCENT3611
0280-4000-06Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211
0280-4000-06Alka-Seltzer Original12 in 1 CARTONTABLET, EFFERVESCENT1211
0280-4000-07Alka-Seltzer Original26 in 1 CARTONTABLET, EFFERVESCENT2611
0280-4000-07Alka-Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-4000-01EA - Each0280-400032606689-6c79-4060-a9aa-b58911c4183512018-04-19
0280-4000-02EA - Each0280-40007141eb74-1de3-4c07-882b-ff231c88e67812017-05-03
0280-4000-03EA - Each0280-400083b8a0a2-63fb-4d7c-bdb3-6bda6370195e12017-05-03
0280-4000-04EA - Each0280-4000ef6e7000-3638-400e-bf65-9c8c723a2c7d12015-01-05
0280-4000-07EA - Each0280-40003e60255b-47dc-4405-a1c5-3fa19568008b12018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSL2
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO2
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL2
ASPIRINACTIVE MOIETYR16CO5Y76E2
BICARBONATE IONACTIVE MOIETYHN1ZRA3Q202

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
0280-40000280-4000-01, 0280-4000-02, 0280-4000-03, 0280-4000-07, 0280-4000-04, 0280-4000-05, 0280-4000-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
ASPIRINR16CO5Y76EACTIB
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
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
ndc (package): 0280-4000-06
ndc (package): 0280-4000-02
ndc (package): 0280-4000-05
ndc (package): 0280-4000-03
ndc (package): 0280-4000-01
ndc (package): 0280-4000-07
ndc (package): 0280-4000-04
ndc (product): 0280-4000
ndc11 (package): 00280400004
ndc11 (package): 00280400006
ndc11 (package): 00280400007
ndc11 (package): 00280400003
ndc11 (package): 00280400002
ndc11 (package): 00280400001
ndc11 (package): 00280400005
spl id: 4526b5f2-3b6b-b295-e063-6294a90ae6c1
spl set id: 5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc

Reported adverse events (FAERS/openFDA)#

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