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#

ProductAlka-Seltzer Pain Relief
Active ingredientASPIRIN
Label structure15 sections

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 over2 tablets every 4 hours, or as directed by a doctordo not exceed 8 tablets in 24 hours
adults 60 years and over2 tablets every 4 hours, or as directed by a doctordo not exceed 4 tablets in 24 hours
children under 12 yearsconsult 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

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSN1
2606079aspirin 325 MG Effervescent Oral TabletSCD1
2606079ASA 325 MG Effervescent Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500603610GTIN-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#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-8251-24Alka-Seltzer Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT21
0280-8251-24Alka-Seltzer Pain Relief12 in 1 CARTONTABLET, EFFERVESCENT121
0280-8251-36Alka-Seltzer Pain Relief18 in 1 CARTONTABLET, EFFERVESCENT181
0280-8251-36Alka-Seltzer Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT21
0280-8251-72Alka-Seltzer Pain Relief36 in 1 CARTONTABLET, EFFERVESCENT361
0280-8251-72Alka-Seltzer Pain Relief2 in 1 POUCHTABLET, EFFERVESCENT21

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-82510280-8251-24, 0280-8251-36, 0280-8251-72

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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 Pain ReliefALKA-SELTZER PAIN RELIEFBayer HealthCare LLC.4975f0ff-0480-7fca-e063-6294a90aef2f2026-01-28WarningsExact identifier
ndc (package): 0280-8251-24
ndc (package): 0280-8251-36
ndc (package): 0280-8251-72
ndc (product): 0280-8251
ndc11 (package): 00280825124
ndc11 (package): 00280825136
ndc11 (package): 00280825172
spl id: 4975f0ff-047f-7fca-e063-6294a90aef2f
spl set id: 4975f0ff-0480-7fca-e063-6294a90aef2f

Reported adverse events (FAERS/openFDA)#

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