Alka-Seltzer Extra Strength

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:19:49

Label at a glance#

ProductAlka-Seltzer Extra Strength
Active ingredientANHYDROUS CITRIC ACID, SODIUM BICARBONATE, ASPIRIN
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

fully dissolve 2 tablets in 4 ounces of water before taking adults and children 12 years and over 2 tablets every 6 hours, or as directed by a doctor do not exceed 7 tablets in 24 hours adults 60 years and over 2 tablets every 6 hours, or as directed by a doctor do not exceed 3 tablets in 24 hours children under 12 years consult a doctor

Storage and handling

each tablet contains: sodium 588 mg store at room temperature. Avoid excessive heat. Alka-Seltzer Extra Strength 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 500 mgAnalgesic
Sodium bicarbonate (heat-treated) 1985 mgAntacid

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

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

Stomach bleeding warning: 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

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.
  • taking a prescription drug for anticoagulation (blood thinning), 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

  • fully dissolve 2 tablets in 4 ounces of water before taking
adults and children 12 years and over2 tablets every 6 hours, or as directed by a doctordo not exceed 7 tablets in 24 hours
adults 60 years and over2 tablets every 6 hours, or as directed by a doctordo not exceed 3 tablets in 24 hours
children under 12 yearsconsult a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 588 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer Extra Strength in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor

Questions or comments?

OTC - QUESTIONS SECTION

1-800-986-0369 (Mon - Fri 9AM - 5PM EST)

PRINCIPAL DISPLAY PANEL - 24 Tablets Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer
®

ANTACID & PAIN RELIEF MEDICINE

FAST

RELIEF

OF:

Acid Indigestion

Upset Stomach

Heartburn with

Headache

Body Aches

XTRA

STRENGTH

24 EFFERVESCENT TABLETS

ASES24ASES24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1872088Alka-Seltzer 500 MG / 1000 MG / 1985 MG Granules for Oral SolutionPSN5
1872085aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Granules for Oral SolutionPSN5
1872088aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Granules for Oral Solution [Alka-Seltzer]SBD5
1872085aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Granules for Oral SolutionSCD5
1872088Alka-Seltzer (aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG) Granules for Oral SolutionSY5
1872085ASA 500 MG / Citric Acid 1000 MG / NaHCO3 1985 MG Granules for Oral SolutionSY5
1872088ASA 500 MG / Citric Acid 1000 MG / NaHCO3 1985 MG Granules for Oral Solution [Alka-Seltzer]SY5
1872085aspirin 500 MG / citric acid 1000 MG / sodium bicarbonate 1985 MG Powder for Oral SolutionSY5
1872088Aspirin 500 MG / Citric Acid 1000 MG / Sodium Bicarbonate 1985 MG Powder for Oral Solution [Alka-Seltzer]SY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0211-24Alka-Seltzer Extra Strength12 in 1 CARTONGRANULE, EFFERVESCENT125
0280-0211-24Alka-Seltzer Extra Strength2 in 1 PACKETGRANULE, EFFERVESCENT25

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-02110280-0211-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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 Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
ndc (package): 0280-0211-24
ndc (product): 0280-0211
ndc11 (package): 00280021124
spl id: 45266611-610c-a481-e063-6394a90a1bf0
spl set id: 49b73bd5-6465-05eb-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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