ALKA-SELTZER ORIGINAL- aspirin, citric acid, sodium bicarbonate tablet

Alka-Seltzer by

Drug Labeling and Warnings

Alka-Seltzer by is a Otc medication manufactured, distributed, or labeled by SALIMEX, S.A., Bayer de México, S.A. de C.V. , Salimex, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 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

● 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

INGREDIENTS AND APPEARANCE

ALKA-SELTZER  ORIGINAL
aspirin, citric acid, sodium bicarbonate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53666-218
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	1916 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	14mm
Flavor		Imprint Code	ALKA;SELTZER
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53666-218-14	150 in 1 BOX	10/03/2017
1	NDC: 53666-218-13	6 in 1 BOX
1	NDC: 53666-218-12	2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/03/2017

Labeler - SALIMEX, S.A. (589201581)

Registrant - SALIMEX, S.A. (589201581)

Establishment
Name	Address	ID/FEI	Business Operations
Bayer de México, S.A. de C.V.		588165709	manufacture(53666-218)

Establishment
Name	Address	ID/FEI	Business Operations
Salimex, S.A.		589201581	relabel(53666-218)