Alka-seltzer ®

Alka-seltzer ®
SPL v1
SPL
SPL Set ID 0c7a60e7-0bde-9aa2-e063-6294a90a3209
Route
ORAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: ALKA;SELTZER Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

Do not use if pouch is torn or open. Alka-Seltzer ® Buffered aspirin (NSAID) /Pain reliever/fever reducer ORIGINAL FLAVOR [Bayer logo] Fast Relief 2 EFFERVESCENT TABLETS

Purpose

Purpose Pain reliever/fever reducer


Medication Information

Purpose

Purpose

Pain reliever/fever reducer

Description

Do not use if pouch is torn or open. Alka-Seltzer ® Buffered aspirin (NSAID) /Pain reliever/fever reducer ORIGINAL FLAVOR [Bayer logo] Fast Relief 2 EFFERVESCENT TABLETS

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

Directions

Directions Fully dissolve 2 tablets in 4 ounces of water before taking. Adults and children 12 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 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.

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
Questions?

Questions? 1-800-986-0369 Dist. By Bayer Healthcare LLC, Whippany, NJ 07981

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.

Pouch Header/pdp

Do not use if pouch is torn or open.

Alka-Seltzer ®

Buffered aspirin (NSAID)/Pain reliever/fever reducer

ORIGINAL FLAVOR

[Bayer logo]

Fast Relief

2 EFFERVESCENT TABLETS

Active Ingredient

Active ingredient (in each tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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

Ask A Doctor Before Use

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
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 directedStomach bleeding warning: This product contains an NSAID, which
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 Or Breast Feeding

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Pharmacist Before Use

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

  • diabetes
  • gout
  • arthritis
Alka Seltzer® Gravity Sleeve (unit Dose) Pdp/label

[Bayer logo]

Alka-

Seltzer ®

Buffered aspirin (NSAID)/

Pain reliever/fever reducer

ORIGINAL FLAVOR

15 PACKETS OF

2 EFFERVESCENT TABLETS

[UPC]


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

Warnings

​Warnings

Directions

Directions Fully dissolve 2 tablets in 4 ounces of water before taking. Adults and children 12 years and over: take 2 tablets every 4 hours, or as directed by a doctor. Do not exceed 8 tablets in 24 hours. Adults 60 years and over: take 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.

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
Questions?

Questions? 1-800-986-0369 Dist. By Bayer Healthcare LLC, Whippany, NJ 07981

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.

Pouch Header/pdp (Pouch Header/PDP)

Do not use if pouch is torn or open.

Alka-Seltzer ®

Buffered aspirin (NSAID)/Pain reliever/fever reducer

ORIGINAL FLAVOR

[Bayer logo]

Fast Relief

2 EFFERVESCENT TABLETS

Active Ingredient (Active ingredient)

Active ingredient (in each tablet)

Buffered aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

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

Ask A Doctor Before Use (Ask a doctor before use)

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
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 directedStomach bleeding warning: This product contains an NSAID, which
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
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

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 (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.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

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

  • diabetes
  • gout
  • arthritis
Alka Seltzer® Gravity Sleeve (unit Dose) Pdp/label (Alka-Seltzer® Gravity Sleeve (unit dose) - PDP/Label)

[Bayer logo]

Alka-

Seltzer ®

Buffered aspirin (NSAID)/

Pain reliever/fever reducer

ORIGINAL FLAVOR

15 PACKETS OF

2 EFFERVESCENT TABLETS

[UPC]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)