Alka-Seltzer Hangover Relief

Manufacturer
Bayer HealthCare LLC.
Effective date
2025-10-16
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:39:24

Label at a glance#

ProductAlka-Seltzer Hangover Relief
Active ingredientCAFFEINE, ASPIRIN
Label structure12 sections

Indications and uses

Uses for the temporary relief of minor aches and pains associated with a hangover helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover for temporary relief of headaches, body aches, and pain alone

Dosage and administration

Directions ● fully dissolve 2 tablets in 4 ounces of water before taking Adults 18 years and over 2 tablets every 6 hours as needed, or as directed by a doctor do not exceed 8 tablets in 24 hours Adults 60 years and over 2 tablets every 6 hours as needed, or as directed by a doctor do not exceed 5 tablets in 24 hours Children under 18 years consult a doctor

Storage and handling

● each tablet contains: potassium 115 mg ● each tablet contains: sodium 371 mg ● Phenylketonurics: Contains Phenylalanine 5.4 mg per tablet ● store at room temperature. Avoid excessive heat

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet)
Aspirin 500 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Pain reliever
Alertness aid/pain reliever aid

Uses

INDICATIONS & USAGE SECTION

Uses

  • for the temporary relief of minor aches and pains associated with a hangover
  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
  • for temporary relief of headaches, body aches, and pain alone

Warnings

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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of
coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this
product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heart beat.
● For occasional use only. Do not use for more than 2 days for a hangover unless directed by a
doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or
continues to recur, consult a doctor.

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:
● hives ● facial swelling ● asthma (wheezing) ● shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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

Caffeine warning

SPL UNCLASSIFIED SECTION

The recommended dose of this product contains about as much caffeine as a cup of
coffee. Limit the use of caffeine- containing medications, foods, or beverages while taking this
product because too much caffeine may cause nervousness, irritability, sleeplessness, and,
occasionally, rapid heart beat.
● For occasional use only. Do not use for more than 2 days for a hangover unless directed by a
doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or
continues to recur, consult a doctor.

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

taking a prescription drug for
● diabetes ● gout ● arthritis

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
  • pain lasts for more than 10 days or gets worse
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
  • new symptoms occur

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

Adults 18 years and over2 tablets every 6 hours as needed, or as directed by a doctordo not exceed 8 tablets in 24 hours
Adults 60 years and over2 tablets every 6 hours as needed, or as directed by a doctordo not exceed 5 tablets in 24 hours
Children under 18 yearsconsult a doctor

Other information

STORAGE AND HANDLING SECTION

● each tablet contains: potassium 115 mg
● each tablet contains: sodium 371 mg
● Phenylketonurics: Contains Phenylalanine 5.4 mg per tablet
● store at room temperature. Avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, aspartame, dimethicone, docusate sodium, FD&C red No. 40, FD&C yellow No. 6, flavor, mannitol, potassium
bicarbonate, povidone, sodium benzoate, sodium bicarbonate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

SPL UNCLASSIFIED SECTION

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 20 Tablet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1536815aspirin 500 MG / caffeine 65 MG Effervescent Oral TabletPSN16
1536815aspirin 500 MG / caffeine 65 MG Effervescent Oral TabletSCD16
1536815ASA 500 MG / Caffeine 65 MG Effervescent Oral TabletSY16

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130016500594963GTIN-13: 0016500594963
EAN-13: 0016500594963
GTIN-12: 016500594963
UPC-A: 016500594963
GTIN storage (14 digits): 00016500594963
89353491_AS_HangoverRelief_Orange_20ct_Tab_Carton_r0.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0084-01Alka-Seltzer Hangover Relief10 in 1 CARTONTABLET, EFFERVESCENT1016
0280-0084-01Alka-Seltzer Hangover Relief2 in 1 POUCHTABLET, EFFERVESCENT216
0280-0084-02Alka-Seltzer Hangover Relief18 in 1 CARTONTABLET, EFFERVESCENT1816
0280-0084-02Alka-Seltzer Hangover Relief2 in 1 POUCHTABLET, EFFERVESCENT216
0280-0084-03Alka-Seltzer Hangover Relief60 in 1 CARTONTABLET, EFFERVESCENT6016
0280-0084-03Alka-Seltzer Hangover Relief2 in 1 POUCHTABLET, EFFERVESCENT216
0280-0084-04Alka-Seltzer Hangover Relief2 in 1 CARTONTABLET, EFFERVESCENT216
0280-0084-04Alka-Seltzer Hangover Relief2 in 1 POUCHTABLET, EFFERVESCENT216
0280-0084-05Alka-Seltzer Hangover Relief2 in 1 POUCHTABLET, EFFERVESCENT216
0280-0084-05Alka-Seltzer Hangover Relief1600 in 1 BOXTABLET, EFFERVESCENT160016
0280-0084-06Alka-Seltzer Hangover Relief30 in 1 CARTONTABLET, EFFERVESCENT3016
0280-0084-06Alka-Seltzer Hangover Relief2 in 1 POUCHTABLET, EFFERVESCENT216

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0280-00840280-0084-01, 0280-0084-02, 0280-0084-03, 0280-0084-04, 0280-0084-05, 0280-0084-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
152025-08-11full-release2026-06-01 01:09:59

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 Hangover ReliefANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.dc235b06-999e-221d-e053-2a95a90a0ce12025-10-16WarningsExact identifier
ndc (package): 0280-0084-05
ndc (package): 0280-0084-06
ndc (package): 0280-0084-02
ndc (package): 0280-0084-03
ndc (package): 0280-0084-01
ndc (package): 0280-0084-04
ndc (product): 0280-0084
ndc11 (package): 00280008403
ndc11 (package): 00280008404
ndc11 (package): 00280008402
ndc11 (package): 00280008406
ndc11 (package): 00280008405
ndc11 (package): 00280008401
spl id: 414c4b16-847c-79f9-e063-6394a90a40bd
spl set id: dc235b06-999e-221d-e053-2a95a90a0ce1

Reported adverse events (FAERS/openFDA)#

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