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

Purpose

Purpose Pain reliever/fever reducer

Description

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


Medication Information

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
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
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

Description

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

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

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.

Active Ingredients

Active ingredients (in each tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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
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
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
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

anhydrous citric acid, sodium bicarbonate

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

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.

Active Ingredients (Active ingredients)

Active ingredients (in each tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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)