Alka-seltzer ®

Alka-seltzer ®
SPL v1
SPL
SPL Set ID 2928e140-c868-5bf5-e063-6394a90ab024
Route
ORAL
Published
Effective Date 2025-02-03
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: ASP;SAC Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • For the temporary relief of minor aches and pains with heartburn, sour stomach, or acid indigestion and upset stomach associated with these symptoms
  • for temporary relief of headaches, body aches, backache and pain alone
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product do not take more than the maximum daily dosage in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

Section 53414-9

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.

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

Directions

● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking

● Do not exceed recommended dose. SEE WARNINGS

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 4 tablets in 24 hours
children under 12 years consult a doctor

Do Not Use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
Allergy Alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock
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 568 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer Heartburn + Pain in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
Inactive Ingredients

none

Questions Or Comments?

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

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

STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

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
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
  • ringing in the ears or a loss of hearing occurs
  • pain get worse or last more than 10 days
  • redness or swelling is present
  • any new symptoms appear
Principal Display Panel 24 Tablet Carton

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

Structured Label Content

Uses
  • For the temporary relief of minor aches and pains with heartburn, sour stomach, or acid indigestion and upset stomach associated with these symptoms
  • for temporary relief of headaches, body aches, backache and pain alone
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product do not take more than the maximum daily dosage in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician.

Section 53414-9 (53414-9)

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.

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

Directions

● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking

● Do not exceed recommended dose. SEE WARNINGS

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 4 tablets in 24 hours
children under 12 years consult a doctor

Do Not Use (Do not use)
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients
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 (Other information)
  • each tablet contains: sodium 568 mg
  • store at room temperature. Avoid excessive heat.
  • Alka-Seltzer Heartburn + Pain in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate
Inactive Ingredients (Inactive ingredients)

none

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

STOMACH WARNING: TO AVOID SERIOUS INJURY, DO NOT TAKE UNTIL TABLET IS COMPLETELY DISSOLVED. IT IS VERY IMPORTANT NOT TO TAKE THIS PRODUCT WHEN OVERLY FULL FROM FOOD OR DRINK. Consult a doctor if severe stomach pain occurs after taking this product.

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
Stop Use and Ask A Doctor If (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
  • ringing in the ears or a loss of hearing occurs
  • pain get worse or last more than 10 days
  • redness or swelling is present
  • any new symptoms appear
Principal Display Panel 24 Tablet Carton (PRINCIPAL DISPLAY PANEL - 24 Tablet Carton)

Ask A Doctor Or Pharmacist Before Use If You Are (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

Advanced Ingredient Data


Raw Label Data

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