ALKA-SELTZER ORIGINAL- aspirin, citric acid, sodium bicarbonate tablet 
SALIMEX, S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Alka-Seltzer Original

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


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

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


Active ingredients (in each tablet)

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

Purpose


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

Uses

for the temporary relief of:

Ask a doctor or pharmacist before use if you are

● presently taking a prescription drug.

Antacids mayinteract 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

● 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?

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

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.

Keep out of reach of children

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

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 4

tablets in 24 hours

children under

12 years

consult a doctor

Other 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

none

Front and Back

Alka Seltzer

ALKA-SELTZER  ORIGINAL
aspirin, citric acid, sodium bicarbonate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53666-218
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE1916 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize14mm
FlavorImprint Code ALKA;SELTZER
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53666-218-14150 in 1 BOX10/03/2017
1NDC:53666-218-136 in 1 BOX
1NDC:53666-218-122 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/03/2017
Labeler - SALIMEX, S.A. (589201581)
Registrant - SALIMEX, S.A. (589201581)
Establishment
NameAddressID/FEIBusiness Operations
Bayer de México, S.A. de C.V. 588165709manufacture(53666-218)
Establishment
NameAddressID/FEIBusiness Operations
Salimex, S.A.589201581relabel(53666-218)

Revised: 7/2021
Document Id: c62adf35-81ff-fde8-e053-2995a90a4c45
Set id: 5aa8704d-ab95-62f0-e053-2991aa0a5ed2
Version: 3
Effective Time: 20210702
 
SALIMEX, S.A.