ALKA-SELTZER ORIGINAL FLAVOR- buffered aspirin, effervescent tablet 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 Lil' Drug Store Products, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Active ingredients (in each tablet)
Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Purpose
Pain reliever/fever reducer

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

Reye's syndrome

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

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

Stomach bleeding warning

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

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

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

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

• diabetes
• gout
• arthritis

Stop use and ask a doctor

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 lasts more than 10 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• ringing in the ears or a loss of hearing occurs

If pregnant

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

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 8 tablets in 24 hours
children under 12 years	ask a doctor

Other information

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

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

Questions or comments

Questions or comments?
1-800-986-0369 (Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

Bayer

Manufacturer: Bayer HealthCare LLC, Whippany, NJ 07981

This product is repackaged by Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404;

1-877-507-6516 (M-F 8AM-4:30PM CST), from a product manufactured by Bayer. 97033C-US-03-22

“Bayer, the Bayer Cross and Alka-Seltzer are registered trademarks of Bayer, used with permission.”

Made in Mexico

PDP/Package

[Bayer cross]

Alka-

Seltzer ®

Buffered aspirin (NSAID) /

Pain Reliever/fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

6

Effervescent Tablets

(3 - 2 count pouches)

[Lil' Drug Store logo]

Alka-Seltzer Original, CVP HEALTH PDP/Package

[Bayer cross]

Alka-

Seltzer ®

Buffered aspirin (NSAID) /

Pain Reliever/fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

4

Effervescent Tablets

(2 - 2 count pouches)

[CVP ® HEALTH logo]

Alka-Seltzer Original, Travel BASIX PDP/Package

Alka-

Seltzer ®

Buffered aspirin (NSAID) /

Pain Reliever/fever reducer

Fast Relief of:

Headache

Backache

Body Aches

Muscle Pain

ORIGINAL FLAVOR

[Bayer cross]

4

Effervescent Tablets

(2 - 2 count pouches)

[Lil' Drug Store logo]

INGREDIENTS AND APPEARANCE

ALKA-SELTZER ORIGINAL FLAVOR 
buffered aspirin, effervescent tablet tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6503
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: 66715-6503-2	2 in 1 CARTON	05/06/2022
1		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 Drug	M013	05/06/2022

ALKA-SELTZER ORIGINAL FLAVOR 
buffered aspirin, effervescent tablet tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9603
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: 66715-9603-2	2 in 1 CARTON	12/01/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-9603-3	3 in 1 CARTON	12/01/2022
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 Drug	M013	12/01/2022

ALKA-SELTZER ORIGINAL FLAVOR 
buffered aspirin, effervescent tablet tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6403
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: 66715-6403-2	2 in 1 CARTON	11/28/2022
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 66715-6403-7	25 in 1 CARTON	04/19/2022
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 66715-6403-8	30 in 1 CARTON	04/19/2022
3		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 Drug	M013	04/19/2022

Labeler - Lil' Drug Store Products, Inc. (093103646)