Alka Seltzer Original

Manufacturer
Savings Distributors LLC
Effective date
2019-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:50

Label at a glance#

ProductAlka Seltzer Original
Active ingredientANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE
Label structure8 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 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

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Anhydrous citric acid 1000 mg

Aspirin 325 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1916 mg

*nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Antacid

Analgesic

Antacid

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

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

When using this product

OTC - WHEN USING SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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.

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

SPL UNCLASSIFIED 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) or www.alkaseltzer.com

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSN1
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN1
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBD1
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD1
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSY1
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY1
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SY1

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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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73097-001-02Alka Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT21
73097-001-02Alka Seltzer Original1 in 1 CARTONTABLET, EFFERVESCENT11
73097-001-40Alka Seltzer Original20 in 1 CARTONTABLET, EFFERVESCENT201
73097-001-40Alka Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT21
73097-001-48Alka Seltzer Original24 in 1 CARTONTABLET, EFFERVESCENT241
73097-001-48Alka Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT21
73097-001-72Alka Seltzer Original36 in 1 CARTONTABLET, EFFERVESCENT361
73097-001-72Alka Seltzer Original2 in 1 POUCHTABLET, EFFERVESCENT21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73097-001ALKA SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE) TABLET, EFFERVESCENT [SAVINGS DISTRIBUTORS LLC]1Legacy NDC, 8 package rows20190709_8d334678-2fda-75c5-e053-2a95a90ae344.zip

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 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73097-00173097-001-02, 73097-001-40, 73097-001-48, 73097-001-72
0280-4000

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 · 2 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 (product): 0280-4000
8d32fcd8-4ae6-1c8d-e053-2a95a90ad4c78d334678-2fda-75c5-e053-2a95a90ae3442019-07-08WarningsExact identifier
spl id: 8d32fcd8-4ae6-1c8d-e053-2a95a90ad4c7
spl set id: 8d334678-2fda-75c5-e053-2a95a90ae344

Reported adverse events (FAERS/openFDA)#

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