Indications and uses
Uses ● temporarily relieves minor aches and pains due to: ● headache ● muscle pain ● backache ● toothache ● menstrual pain ● colds ● minor pain of arthritis ● temporarily reduces fever
Alka-Seltzer Original Flavor
- Manufacturer
- Navajo Manufacturing Company Inc.
- Effective date
- 2024-10-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:22:39
Label at a glance#
ProductAlka-Seltzer Original Flavor
Active ingredientASPIRIN
Label structure9 sections
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
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Buffered aspirin 325 mg (NSAID)*
Purpose
Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
Uses
Uses
● temporarily relieves minor aches and pains due to:
● headache ● muscle pain ● backache
● toothache ● menstrual pain ● colds
● minor pain of arthritis
● temporarily reduces fever
Warnings
Warnings
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
OTC - DO NOT USE SECTION
Do not use
● 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
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
● 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 taking a prescription drug for
● diabetes ● gout ● arthritis
OTC - STOP USE SECTION
Stop use and ask a doctor if
● 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
● pain gets worse or last more than 10 days
● fever gets worse or last more than 3 days
● redness or swelling is present
● new symptoms occur
● ringing in the ears or a loss of hearing occurs
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 at 20 weeks or later in 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
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 |
Other Information
● each tablet contains: sodium 568 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Original Flavor in water contains principally the analgesic sodium acetylsalicylate
Inactive ingredients
anhydrous citric acid, sodium bicarbonate
Questions or comments?
1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67751-219-01 | Alka-Seltzer Original Flavor | 1 in 1 CARTON | TABLET, EFFERVESCENT | 1 | 2 | |
| 67751-219-01 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 2 | |
| 67751-219-02 | Alka-Seltzer Original Flavor | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 2 | |
| 67751-219-02 | Alka-Seltzer Original Flavor | 2 in 1 CARTON | TABLET, EFFERVESCENT | 2 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Original Flavor
- ANHYDROUS CITRIC ACID
- SODIUM BICARBONATE
- ASPIRIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 67751-219 | 67751-219-01, 67751-219-02 |
| 0280-0087 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ASPIRIN | R16CO5Y76E | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Bayer HealthCare LLC. | 07478020-5ba0-3b67-e054-00144ff88e88 | 2025-12-04 | Warnings | 0280-0087 |
| Alka-Seltzer Original Flavor | ALKA-SELTZER ORIGINAL FLAVOR | Navajo Manufacturing Company Inc. | f70875ab-241c-4876-e053-6294a90a8092 | 2024-10-03 | Warnings | 67751-219-01 67751-219-02 67751-219 67751021902 67751021901 23960e84-c184-a473-e063-6394a90ad146 f70875ab-241c-4876-e053-6294a90a8092 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.