FDA.reportPublic FDA data

Alka-Seltzer

Manufacturer
Select Consumer Group
Effective date
2026-05-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:36:27

Label at a glance#

ProductAlka-Seltzer Original
Active ingredientANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE
Label structure9 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 productdo 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)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22771166

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708018293GTIN-13: 0655708018293
EAN-13: 0655708018293
GTIN-12: 655708018293
UPC-A: 655708018293
GTIN storage (14 digits): 00655708018293		2401829262 - Alka-Seltzer Original - 1829-6.jpg
BarcodeEAN-130655708118290GTIN-13: 0655708118290
EAN-13: 0655708118290
GTIN-12: 655708118290
UPC-A: 655708118290
GTIN storage (14 digits): 00655708118290		2511829021 - Alka-Seltzer Original - 1829-1.jpg
BarcodeEAN-130655708218297GTIN-13: 0655708218297
EAN-13: 0655708218297
GTIN-12: 655708218297
UPC-A: 655708218297
GTIN storage (14 digits): 00655708218297		2521829021 - Alka-Seltzer Original - 1829-2.jpg
BarcodeEAN-130655708318294GTIN-13: 0655708318294
EAN-13: 0655708318294
GTIN-12: 655708318294
UPC-A: 655708318294
GTIN storage (14 digits): 00655708318294		2631829096 - Alka-Seltzer Original - 1829-7.jpg

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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 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

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
85237-182985237-1829-1, 85237-1829-0, 85237-1829-2, 85237-1829-3, 85237-1829-4, 85237-1829-6, 85237-1829-7
0280-4000

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-18full-release2026-06-01 01:10:55

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
ndc (package): 85237-1829-6
ndc (package): 85237-1829-4
ndc (package): 85237-1829-7
ndc (package): 85237-1829-1
ndc (package): 85237-1829-0
ndc (package): 85237-1829-3
ndc (package): 85237-1829-2
ndc (product): 85237-1829
ndc11 (package): 85237182907
ndc11 (package): 85237182901
ndc11 (package): 85237182903
ndc11 (package): 85237182906
ndc11 (package): 85237182900
ndc11 (package): 85237182902
ndc11 (package): 85237182904
spl id: 529c597f-c4b1-98d4-e063-6394a90adba7
spl set id: 3ca80d74-1e8b-49d9-e063-6394a90a4312
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
ndc (product): 0280-4000

Reported adverse events (FAERS/openFDA)#

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