Alka Seltzer Original

Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2023-03-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:35:28

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        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

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       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

• do not use if pouch is opened
• 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

Water

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

Alka Seltzer OriginalAlka Seltzer Original

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
67751-14367751-143-01, 67751-143-02
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
f5db5155-47d3-b350-e053-2995a90a1370fbf52eee-b307-4640-8f90-909bebe54a422023-03-01WarningsExact identifier
spl id: f5db5155-47d3-b350-e053-2995a90a1370
spl set id: fbf52eee-b307-4640-8f90-909bebe54a42

Reported adverse events (FAERS/openFDA)#

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