FDA.reportPublic FDA data

Alka-Seltzer

Manufacturer
Lil' Drug Store Products, Inc
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:18:11

Label at a glance#

ProductAlka-Seltzer
Active ingredientANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE
Label structure9 sections

Indications and uses

for the 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#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Anhydrous citric acid 1000 mgAntacid
Aspirin 325 mg (NSAID) * Analgesic
Sodium bicarbonate (heat-treated) 1916 mgAntacid

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

for the 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

OTC - DO NOT USE SECTION

Do not use if you are allergic to aspirin or any other pain reliever/fever reducer

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

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

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 during the last 3 months of 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

  • 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 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) or www.alkaseltzer.com

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See new warnings information

Alka-
Seltzer ®

Anhydrous Citric Acid/Antacid
Aspirin ( NSAID)/Analgesic
Sodium Bicarbonate/Antacid

FAST
RELIEF
OF:
Acid Indigestion
Upset Stomach
Heartburn with
Headache
Body Aches

ORIGINAL

2
EFFERVESCENT
TABLETS

Lil'
Drug Store ®

PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton
PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Anhydrous Citric AcidACTIVE INGREDIENTXF417D3PSL2
AspirinACTIVE INGREDIENTR16CO5Y76E2
Sodium BicarbonateACTIVE INGREDIENT8MDF5V39QO2
Anhydrous Citric AcidACTIVE MOIETYXF417D3PSL2
AspirinACTIVE MOIETYR16CO5Y76E2
Bicarbonate IonACTIVE MOIETYHN1ZRA3Q202

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
66715-970366715-9703-1, 66715-9703-2, 66715-9703-0, 66715-9703-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
0c8f899a-43bf-c969-e063-6394a90a4c1ffbfa46b6-1773-4053-b323-66f4321d64722023-12-15WarningsExact identifier
spl id: 0c8f899a-43bf-c969-e063-6394a90a4c1f
spl set id: fbfa46b6-1773-4053-b323-66f4321d6472

Reported adverse events (FAERS/openFDA)#

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