Alka-Seltzer

Manufacturer
Impulsora Sahuayo, S.A. de C.V | Bayer de México, S.A. de C.V.
Effective date
2021-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:41

Label at a glance#

ProductAlka-Seltzer Original
Active ingredientANHYDROUS CITRIC ACID, SODIUM BICARBONATE, ASPIRIN
Label structure15 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

Label contents#

Full prescribing information#

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

Warnings

WARNINGS 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:
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

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

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Citric acid
Aspirin (NSAID)*
Sodium bicarbonate (heat-treated)
*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION


Citric acid 1000 mg...............................….……Antacid
Aspirin 325 mg (NSAID)*…..………………….…………..Analgesic
Sodium bicarbonate (heat-treated) 1916 mg.……………...Antacid
*nonsteroidal anti-inflammatory drug

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

● presently taking a prescription drug.

Antacids mayinteract with certain prescription drugs.
● taking a prescription drug for diabetes, gout, or arthritis

When using this product

OTC - WHEN USING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

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 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.

Keep out of reach of children

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 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

Other information

OTHER SAFETY INFORMATION

● 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

Front and Back

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alka SeltzerAlka Seltzer

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69670-218-142022-07-29C16284748780-1e4f33bdf-a55e-d8a0-e053-dadaa90a6e4eAlka-Seltzer Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69670-218-12Alka-SeltzerOriginal2 in 1 POUCHTABLET21
69670-218-13Alka-SeltzerOriginal6 in 1 BOXTABLET61
69670-218-14Alka-SeltzerOriginal150 in 1 BOXTABLET1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69670-218ALKA-SELTZER ORIGINAL (ASPIRIN, CITRIC ACID, SODIUM BICARBONATE) TABLET [IMPULSORA SAHUAYO, S.A. DE C.V]1Legacy NDC, 3 package rows20210729_c83bec95-c837-656f-e053-2a95a90a41bb.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69670-21869670-218-12, 69670-218-13, 69670-218-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
c83bf77e-5e24-3f48-e053-2a95a90ae5f8c83bec95-c837-656f-e053-2a95a90a41bb2021-07-28WarningsExact identifier
spl id: c83bf77e-5e24-3f48-e053-2a95a90ae5f8
spl set id: c83bec95-c837-656f-e053-2a95a90a41bb

Reported adverse events (FAERS/openFDA)#

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