FDA.reportPublic FDA data

Alka-Seltzer Original Flavor

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:03:34

Label at a glance#

ProductAlka-Seltzer Original Flavor
Active ingredientASPIRIN
Label structure12 sections

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

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 8 tablets in 24 hours children under 12 years ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)
Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

Uses

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

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION


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

SPL UNCLASSIFIED SECTION

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

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

Do not use

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

Ask a doctor before use if

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

Ask a doctor or pharmacist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for

  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor

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 lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or a loss of hearing occurs

If pregnant

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.

Keep out of reach

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 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 8 tablets in 24 hours
children under 12 yearsask a doctor

Other information

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

Questions or comments

OTC - QUESTIONS SECTION

Questions or comments?
1-800-986-0369 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Bayer

Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981


This product is repackaged by Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404;

1-877-507-6516 (M-F 8AM-4:30PM CST), from a product manufactured by Bayer. 97033C-US-03-22


“Bayer, the Bayer Cross and Alka-Seltzer are registered trademarks of Bayer, used with permission.”


Made in Mexico

PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Bayer cross]

Alka-

Seltzer ®

Buffered aspirin (NSAID) /

Pain Reliever/fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

6

Effervescent Tablets

(3 - 2 count pouches)

[Lil' Drug Store logo]

PDP/PackagePDP/Package

Alka-Seltzer Original, CVP HEALTH PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Bayer cross]

Alka-

Seltzer ®

Buffered aspirin (NSAID) /

Pain Reliever/fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

4

Effervescent Tablets

(2 - 2 count pouches)

[CVP ® HEALTH logo]

PDP/PackagePDP/Package

Alka-Seltzer Original, Travel BASIX PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka-

Seltzer ®

Buffered aspirin (NSAID) /

Pain Reliever/fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

[Bayer cross]

4

Effervescent Tablets

(2 - 2 count pouches)

[Lil' Drug Store logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2606079aspirin 325 MG Effervescent Oral TabletPSN3
2606079aspirin 325 MG Effervescent Oral TabletSCD3
2606079ASA 325 MG Effervescent Oral TabletSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
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
66715-6403-2Alka-Seltzer Original Flavor2 in 1 CARTONTABLET, EFFERVESCENT23
66715-6403-2Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT23
66715-6403-7Alka-Seltzer Original Flavor25 in 1 CARTONTABLET, EFFERVESCENT253
66715-6403-7Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT23
66715-6403-8Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT23
66715-6403-8Alka-Seltzer Original Flavor30 in 1 CARTONTABLET, EFFERVESCENT303
66715-6503-2Alka-Seltzer Original Flavor2 in 1 CARTONTABLET, EFFERVESCENT23
66715-6503-2Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT23
66715-9603-2Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT23
66715-9603-2Alka-Seltzer Original Flavor2 in 1 CARTONTABLET, EFFERVESCENT23
66715-9603-3Alka-Seltzer Original Flavor3 in 1 CARTONTABLET, EFFERVESCENT33
66715-9603-3Alka-Seltzer Original Flavor2 in 1 POUCHTABLET, EFFERVESCENT23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6403ALKA-SELTZER ORIGINAL FLAVOR (BUFFERED ASPIRIN, EFFERVESCENT TABLET) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, 6 package rows20231207_ea5df8be-a08c-5fa3-e053-2995a90a0bac.zip
66715-6503ALKA-SELTZER ORIGINAL FLAVOR (BUFFERED ASPIRIN, EFFERVESCENT TABLET) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, 2 package rows20231207_ea5df8be-a08c-5fa3-e053-2995a90a0bac.zip
66715-9603ALKA-SELTZER ORIGINAL FLAVOR (BUFFERED ASPIRIN, EFFERVESCENT TABLET) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]3Current NDC, Legacy NDC, 4 package rows20231207_ea5df8be-a08c-5fa3-e053-2995a90a0bac.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-650366715-6503-2
66715-960366715-9603-2, 66715-9603-3
66715-640366715-6403-2, 66715-6403-7, 66715-6403-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ASPIRINR16CO5Y76EACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ASPIRINR16CO5Y76EACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ASPIRINR16CO5Y76EACTIB

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 Original FlavorBUFFERED ASPIRIN, EFFERVESCENT TABLETLil' Drug Store Products, Inc.ea5df8be-a08c-5fa3-e053-2995a90a0bac2023-12-06WarningsExact identifier
ndc (package): 66715-6403-8
ndc (package): 66715-9603-3
ndc (package): 66715-6403-7
ndc (package): 66715-6503-2
ndc (package): 66715-9603-2
ndc (package): 66715-6403-2
ndc (product): 66715-6403
ndc (product): 66715-9603
ndc (product): 66715-6503
ndc11 (package): 66715960303
ndc11 (package): 66715640308
ndc11 (package): 66715650302
ndc11 (package): 66715960302
ndc11 (package): 66715640302
ndc11 (package): 66715640307
spl id: 0bd9a2db-1735-a097-e063-6294a90a3274
spl set id: ea5df8be-a08c-5fa3-e053-2995a90a0bac

Reported adverse events (FAERS/openFDA)#

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