Alka-Seltzer Original Flavor

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:19:36

Label at a glance#

ProductAlka-Seltzer Original Flavor
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

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

● fully dissolve 2 tablets in 4 ounces of water before taking

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 Original Flavor 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

Alka-Seltzer Original Flavor 24ctAlka-Seltzer Original Flavor 24ct

Alka-Seltzer

Buffered Aspirin (NSAID) / Pain reliever / fever reducer

Fast Relief of:
Headache
Backache
Body Aches
Muscle Pain

ORIGINAL FLAVOR

24 EFFERVESCENT TABLETS

(12 - 2 count pouches)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSN10
2606079aspirin 325 MG Effervescent Oral TabletSCD10
2606079ASA 325 MG Effervescent Oral TabletSY10

DailyMed Pharmacologic Classes#

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

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
0280-0087-01Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-01Alka-Seltzer Original Flavor6 in 1 CARTONTABLET, EFFERVESCENT610
0280-0087-02Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-02Alka-Seltzer Original Flavor18 in 1 CARTONTABLET, EFFERVESCENT1810
0280-0087-03Alka-Seltzer Original Flavor36 in 1 CARTONTABLET, EFFERVESCENT3610
0280-0087-03Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-04Alka-Seltzer Original Flavor12 in 1 CARTONTABLET, EFFERVESCENT1210
0280-0087-04Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-06Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT210
0280-0087-06Alka-Seltzer Original Flavor58 in 1 CARTONTABLET, EFFERVESCENT5810

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANHYDROUS CITRIC ACIDACTIVE INGREDIENTXF417D3PSL1
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
SODIUM BICARBONATEACTIVE INGREDIENT8MDF5V39QO1
ANHYDROUS CITRIC ACIDACTIVE MOIETYXF417D3PSL1
ASPIRINACTIVE MOIETYR16CO5Y76E1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR11
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA01
POVIDONEINACTIVE INGREDIENTFZ989GH94E1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EU1

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
0280-00870280-0087-04, 0280-0087-02, 0280-0087-03, 0280-0087-01, 0280-0087-06

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 390 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONEPOVIDONEFZ989GH94ETABLET, ORALLY DISINTEGRATING / ORAL15.03 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route
126 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SUSPENSION / ORAL420 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SOLUTION / ORAL233 mgExact identifier — unii+route
102 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
126 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1SYRUP / ORAL0.63 mg/5mlExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, FOR SUSPENSION / ORAL15 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii+route
102 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESOLUTION / ORAL3000 mgExact identifier — unii+route
126 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1GRANULE, EFFERVESCENT / ORAL30 mgExact identifier — unii+route
102 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
114 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FOR SUSPENSION / ORAL2 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94EDROPS / ORALNAExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
126 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
114 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL78 mgExact identifier — unii+route
102 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0TABLET, COATED / ORAL1 mgExact identifier — unii+route
48 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route
114 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii+route
126 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii+route
114 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETROCHE / ORAL30 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, CHEWABLE / ORAL48 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE / ORAL300 mgExact identifier — unii+route
126 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER, FOR SOLUTION / ORAL233 mgExact identifier — unii+route
102 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL20 mgExact identifier — unii+route
48 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
114 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii+route
114 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii+route
126 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL20 mgExact identifier — unii+route
48 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ESUSPENSION / ORAL20 mg/5mlExact identifier — unii+route
126 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1CAPSULE, EXTENDED RELEASE / ORAL3 mgExact identifier — unii+route
102 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route
126 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, ORALLY DISINTEGRATING / ORAL180 mgExact identifier — unii+route
102 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SOLUTION / ORAL98 mgExact identifier — unii+route
114 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0TABLET, FILM COATED / ORAL6 mgExact identifier — unii+route
48 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
114 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
102 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET / ORAL30 mgExact identifier — unii+route
114 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, EXTENDED RELEASE / ORAL56 mgExact identifier — unii+route
126 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSUSPENSION, EXTENDED RELEASE / ORAL24 mgExact identifier — unii+route
114 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1TABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
102 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, COATED PELLETS / ORAL10.03 mgExact identifier — unii+route
126 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii+route
126 equally ranked IID candidates
DOCUSATE SODIUMDOCUSATE SODIUMF05Q2T2JA0SUSPENSION, EXTENDED RELEASE / ORAL0.77 mgExact identifier — unii+route
48 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1SUSPENSION / ORAL23 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii+route
102 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUSYRUP / ORAL80 mgExact identifier — unii+route
114 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE / ORALNAExact identifier — unii+route
126 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUTABLET, DELAYED RELEASE / ORAL0.34 mgExact identifier — unii+route
114 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii+route
114 equally ranked IID candidates
sodium benzoateSODIUM BENZOATEOJ245FE5EUPOWDER, FOR SUSPENSION / ORAL160 mgExact identifier — unii+route
114 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1LOZENGE / ORAL136 mgExact identifier — unii+route
102 equally ranked IID candidates
ASPARTAMEASPARTAMEZ0H242BBR1POWDER / ORAL63 mgExact identifier — unii+route
102 equally ranked IID candidates

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 Original FlavorALKA-SELTZER ORIGINAL FLAVORBayer HealthCare LLC.07478020-5ba0-3b67-e054-00144ff88e882025-12-04WarningsExact identifier
ndc (package): 0280-0087-01
ndc (package): 0280-0087-04
ndc (package): 0280-0087-02
ndc (package): 0280-0087-06
ndc (package): 0280-0087-03
ndc (product): 0280-0087
ndc11 (package): 00280008704
ndc11 (package): 00280008701
ndc11 (package): 00280008703
ndc11 (package): 00280008702
ndc11 (package): 00280008706
spl id: 452648e2-82a6-84f5-e063-6394a90a6df1
spl set id: 07478020-5ba0-3b67-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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