Alka-Seltzer Pain Relief
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2026-01-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:36:45
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Buffered aspirin 325 mg (NSAID)*
OTC - PURPOSE SECTION
Pain reliever/fever reducer
*nonsteroidal anti-inflammatory drug
INDICATIONS & USAGE SECTION
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 SECTION
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
STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.
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.
DOSAGE & ADMINISTRATION SECTION
Directions
● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking
● Do not exceed recommended dose. SEE WARNINGS.
| 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 SAFETY INFORMATION
Other information
● each tablet contains: sodium 568 mg
● store at room temperature. Avoid excessive heat.
● Alka-Seltzer Pain Relief in water contains principally the analgesic sodium acetylsalicylate
INACTIVE INGREDIENT SECTION
Inactive Ingredients anhydrous citric acid, sodium bicarbonate
OTC - QUESTIONS SECTION
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 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0016500603610 | GTIN-13: 0016500603610 EAN-13: 0016500603610 GTIN-12: 016500603610 UPC-A: 016500603610 GTIN storage (14 digits): 00016500603610 | ALKA-SELTZER Pain Tablet Carton.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-8251-24 | Alka-Seltzer Pain Relief | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 | |
| 0280-8251-24 | Alka-Seltzer Pain Relief | 12 in 1 CARTON | TABLET, EFFERVESCENT | 12 | 1 | |
| 0280-8251-36 | Alka-Seltzer Pain Relief | 18 in 1 CARTON | TABLET, EFFERVESCENT | 18 | 1 | |
| 0280-8251-36 | Alka-Seltzer Pain Relief | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 | |
| 0280-8251-72 | Alka-Seltzer Pain Relief | 36 in 1 CARTON | TABLET, EFFERVESCENT | 36 | 1 | |
| 0280-8251-72 | Alka-Seltzer Pain Relief | 2 in 1 POUCH | TABLET, EFFERVESCENT | 2 | 1 |
Products#
Every source-derived product name is available through these pages.
- Alka-Seltzer Pain Relief
- ANHYDROUS CITRIC ACID
- SODIUM BICARBONATE
- ASPIRIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0280-8251 | 0280-8251-24, 0280-8251-36, 0280-8251-72 |
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 Pain Relief | ALKA-SELTZER PAIN RELIEF | Bayer HealthCare LLC. | 4975f0ff-0480-7fca-e063-6294a90aef2f | 2026-01-28 | Warnings | 0280-8251-24 0280-8251-36 0280-8251-72 0280-8251 00280825124 00280825136 00280825172 4975f0ff-047f-7fca-e063-6294a90aef2f 4975f0ff-0480-7fca-e063-6294a90aef2f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
