FDA.reportPublic FDA data

ALKA-SELTZER ORIGINAL

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:19:13

Label at a glance#

ProductALKA-SELTZER ORIGINAL
Active ingredientANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE
Label structure12 sections

Indications and uses

for the temporary relief of: heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains upset stomach with headache from overindulgence in food or drink headache, body aches, and pain alone

Dosage and administration

• 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 4 tablets in 24 hours children under 12 years consult a doctor

Storage and handling

each tablet contains: sodium 567 mg store at room temperature. Avoid excessive heat. Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Anhydrous citric acid 1000 mg
Aspirin 325 mg (NSAID) * 1

Sodium bicarbonate (heat-treated) 1916 mg

1 nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Antacid

Analgesic

Antacid

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of:

  • heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains
  • upset stomach with headache from overindulgence in food or drink
  • headache, body aches, and pain alone

Warnings

WARNINGS SECTION

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

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

  • presently taking a prescription drug. Antacids may interact with certain prescription drugs.
  • taking a prescription drug for diabetes, gout, or arthritis

When using this product do not exceed recommended dosage

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
  • symptoms get worse or last more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs
  • new symptoms occur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center
right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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 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 Information

STORAGE AND HANDLING SECTION

  • each tablet contains: sodium 567 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION


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

SPL UNCLASSIFIED SECTION

Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981

This product is packaged 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.

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

25 Count Box

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

50 Effervescent Tablets
(25 - 2 count pouches)

Alka-
Seltzer ®

Buffered aspirin (NSAID) /

Pain reliever / fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

50 Effervescent Tablets
(25 - 2 count pouches)

Alka Seltzer 25 count boxAlka Seltzer 25 count box

30 Count Box

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

60 Effervescent Tablets
(30 - 2 count pouches)

Alka Seltzer 30 count boxAlka Seltzer 30 count box

CVP 4 Count Carton

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

4

Effervescent Tablets
(2 - 2 count pouches)

CVP

HEALTH

Alka Seltzer CVP 4ctAlka Seltzer CVP 4ct

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29485-6503ALKA-SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE TABLET, EFFERVESCENT) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]5Unmatched20231207_f05a1c0a-58ef-3810-e053-2a95a90a82ec.zip
29485-7535ALKA-SELTZER ORIGINAL (ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE TABLET, EFFERVESCENT) TABLET, EFFERVESCENT [LIL' DRUG STORE PRODUCTS, INC.]5Legacy NDC20231207_f05a1c0a-58ef-3810-e053-2a95a90a82ec.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29485-650329485-6503-3
29485-753529485-7535-2, 29485-7535-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
ASPIRINR16CO5Y76EACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
ASPIRINR16CO5Y76EACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB

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
0bd96cdb-fc6e-b965-e063-6394a90a9373f05a1c0a-58ef-3810-e053-2a95a90a82ec2023-12-06WarningsExact identifier
spl id: 0bd96cdb-fc6e-b965-e063-6394a90a9373
spl set id: f05a1c0a-58ef-3810-e053-2a95a90a82ec

Reported adverse events (FAERS/openFDA)#

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