Alka-seltzer ®

Alka-seltzer ®
SPL v3
SPL
SPL Set ID ea5df8be-a08c-5fa3-e053-2995a90a0bac
Route
ORAL
Published
Effective Date 2022-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Anhydrous Citric Acid Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: Alka;Seltzer Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-19

Description

Active ingredients (in each tablet) Buffered aspirin 325 mg (NSAID)* *nonsteroidal anti-inflammatory drug

Purpose

Purpose Pain reliever/fever reducer


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

Active ingredients (in each tablet) Buffered aspirin 325 mg (NSAID)* *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
Section 42229-5

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

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
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
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.

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]

Allergy Alert

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

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

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.

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
Active Ingredients

Active ingredients (in each tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

Questions Or Comments

Questions or comments?

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

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
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
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
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]


Structured Label Content

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
Section 42229-5 (42229-5)

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

Purpose

Purpose

Pain reliever/fever reducer

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
Do Not Use (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
If Pregnant (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.

Pdp/package (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]

Allergy Alert (Allergy alert)

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

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
Reye's Syndrome (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.

Keep Out of Reach (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.

Other Information (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
Active Ingredients (Active ingredients)

Active ingredients (in each tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

Questions Or Comments (Questions or comments)

Questions or comments?

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

Stomach Bleeding Warning (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
Stop Use and Ask A Doctor (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
Ask A Doctor Before Use If (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)

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

  • diabetes
  • gout
  • arthritis
Alka Seltzer Original, Cvp Health Pdp/package (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 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]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)