Alka-seltzer ®

Alka-seltzer ®
SPL v2
SPL
SPL Set ID da6b52eb-694a-fa8e-e053-2a95a90aaa18
Route
ORAL
Published
Effective Date 2008-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Citric Acid (1000 mg) Aspirin (325 mg) Bicarbonate Ion (1916 mg)

Identifiers & Packaging

Pill Appearance
Imprint: ALKA;SELTZER Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2008-01-17 Until 2026-06-01

Description

Alka-Seltzer ® Anhydrous citric acid / Antacid Aspirin ( NSAID ) / Analgesic Sodium bicarbonate / Antacid [Bayer logo] ORIGINAL Fast Relief Do not use if pouch is torn or open 2 EFFERVESCENT TABLETS


Medication Information

Description

Alka-Seltzer ® Anhydrous citric acid / Antacid Aspirin ( NSAID ) / Analgesic Sodium bicarbonate / Antacid [Bayer logo] ORIGINAL Fast Relief Do not use if pouch is torn or open 2 EFFERVESCENT TABLETS

Uses

for the temporary relief of:

• heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains

• upset stomach with headache from overindulgence in food or drink

• headache, body aches, and pain alone

Section 50565-1

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

Section 50566-9

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

• symptoms get worse or last more than 10 days

• redness or swelling is present

• ringing in the ears or a loss of hearing occurs

• new symptoms occur

Section 50567-7

When using this product do not exceed recommended dosage

Section 50568-5

Ask a doctor or pharmacist before use if you are

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.

• taking a prescription drug for diabetes, gout, or arthritis

Section 50569-3

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

Section 50570-1

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

Section 51945-4

Alka-

Seltzer ®

Anhydrous citric acid / Antacid

Aspirin (NSAID) / Analgesic

Sodium bicarbonate / Antacid

[Bayer logo]

ORIGINAL

15 PACKETS OF

2 EFFERVESCENT TABLETS

www.lildrugstore.com

[UPC]

Section 53413-1

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

Bayer HealthCare LLC, P.O. Box 1910, Morristown, NJ 07962-1910

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1
Active ingredients (in each tablet) Purpose
Anhydrous citric acid 1000 mg Antacid
Aspirin 325 mg (NSAID)* Analgesic
Sodium bicarbonate (heat-treated) 1916 mg Antacid

*nonsteroidal anti-inflammatory drug

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.

Pouch Header

Alka-Seltzer ®

Anhydrous citric acid / Antacid

Aspirin ( NSAID) / Analgesic

Sodium bicarbonate / Antacid

[Bayer logo]

ORIGINAL Fast Relief

Do not use if pouch is torn or open

2 EFFERVESCENT TABLETS

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.

Other Information

Each tablet contains: sodium 567 mg. Store at room temperature. Avoid excessive heat. Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate.

Inactive Ingredients

none

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


Structured Label Content

Uses

for the temporary relief of:

• heartburn, acid indigestion, and sour stomach when accompanied with headache or body aches and pains

• upset stomach with headache from overindulgence in food or drink

• headache, body aches, and pain alone

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

• symptoms get worse or last more than 10 days

• redness or swelling is present

• ringing in the ears or a loss of hearing occurs

• new symptoms occur

Section 50567-7 (50567-7)

When using this product do not exceed recommended dosage

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• presently taking a prescription drug. Antacids may interact with certain prescription drugs.

• taking a prescription drug for diabetes, gout, or arthritis

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Alka-

Seltzer ®

Anhydrous citric acid / Antacid

Aspirin (NSAID) / Analgesic

Sodium bicarbonate / Antacid

[Bayer logo]

ORIGINAL

15 PACKETS OF

2 EFFERVESCENT TABLETS

www.lildrugstore.com

[UPC]

Section 53413-1 (53413-1)

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

Bayer HealthCare LLC, P.O. Box 1910, Morristown, NJ 07962-1910

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purpose
Anhydrous citric acid 1000 mg Antacid
Aspirin 325 mg (NSAID)* Analgesic
Sodium bicarbonate (heat-treated) 1916 mg Antacid

*nonsteroidal anti-inflammatory drug

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.

Pouch Header

Alka-Seltzer ®

Anhydrous citric acid / Antacid

Aspirin ( NSAID) / Analgesic

Sodium bicarbonate / Antacid

[Bayer logo]

ORIGINAL Fast Relief

Do not use if pouch is torn or open

2 EFFERVESCENT TABLETS

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.

Other Information (Other information)

Each tablet contains: sodium 567 mg. Store at room temperature. Avoid excessive heat. Alka-Seltzer in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate.

Inactive Ingredients (Inactive ingredients)

none

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


Advanced Ingredient Data


Raw Label Data

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