ALKA-SELTZER ORIGINAL FLAVOR tablet, effervescent

Alka-Seltzer Original Flavor by

Drug Labeling and Warnings

Alka-Seltzer Original Flavor by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Buffered aspirin 325 mg (NSAID)*

Purpose

Pain reliever/fever reducer



*nonsteroidal anti-inflammatory drug

Uses

Uses

● temporarily relieves minor aches and pains due to:

● headache ● muscle pain ● backache

● toothache ● menstrual pain ● colds

● minor pain of arthritis

● temporarily reduces fever

Warnings

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

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

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

Ask a doctor or pharmacist before use if you are taking a prescription drug for

● diabetes ● gout ● arthritis

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

● pain gets worse or last more than 10 days

● fever gets worse or last more than 3 days

● redness or swelling is present

● new symptoms occur

● ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding, 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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 568 mg

● store at room temperature. Avoid excessive heat.

● Alka-Seltzer Original Flavor in water contains principally the analgesic sodium acetylsalicylate

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALKA-SELTZER ORIGINAL FLAVOR 
alka-seltzer original flavor tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-219(NDC:0280-0087)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO)	1916 mg

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor		Imprint Code	Alka;Seltzer
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-219-01	1 in 1 CARTON	03/16/2023
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-219-02	2 in 1 CARTON	03/16/2023
2		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	03/16/2023

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-219) , repack(67751-219)