Alka-seltzer Pain Relief Ui1600130

Alka-seltzer Pain Relief Ui1600130
SPL v1
SPL
SPL Set ID 4975f0ff-0480-7fca-e063-6294a90aef2f
Route
ORAL
Published
Effective Date 2026-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (1000 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 2025-12-01

Description

Active ingredient (in each tablet) Buffered aspirin 325 mg (NSAID)*


Medication Information

Warnings and Precautions

Warnings

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.

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

· hives · facial swelling · asthma (wheezing) · shock

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.

Indications and Usage

Uses

● temporarily relieves minor aches and pains due to:

● headache ● muscle pain ● backache

● toothache ● menstrual pain ● colds

● minor pain of arthritis

● temporarily reduces fever

Dosage and Administration

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

Description

Active ingredient (in each tablet) Buffered aspirin 325 mg (NSAID)*

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

● pain gets worse or last more than 10 days

● fever gets worse or last more than 3 days

● redness or swelling is present

● new symptoms occur

● ringing in the ears or a loss of hearing occurs

Section 50568-5

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

● diabetes ● gout ● 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 51727-6

Inactive Ingredients anhydrous citric acid, sodium bicarbonate

Section 51945-4

Section 53413-1

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

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

Pain reliever/fever reducer



*nonsteroidal anti-inflammatory drug

Section 55106-9

Active ingredient (in each tablet)

Buffered aspirin 325 mg (NSAID)*

Section 60561-8

Other information

each tablet contains: sodium 568 mg

● store at room temperature. Avoid excessive heat.

● Alka-Seltzer Pain Relief in water contains principally the analgesic sodium acetylsalicylate


Structured Label Content

Indications and Usage (34067-9)

Uses

● temporarily relieves minor aches and pains due to:

● headache ● muscle pain ● backache

● toothache ● menstrual pain ● colds

● minor pain of arthritis

● temporarily reduces fever

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

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.

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

· hives · facial swelling · asthma (wheezing) · shock

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.

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

● pain gets worse or last more than 10 days

● fever gets worse or last more than 3 days

● redness or swelling is present

● new symptoms occur

● ringing in the ears or a loss of hearing occurs

Section 50568-5 (50568-5)

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

● diabetes ● gout ● 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 51727-6 (51727-6)

Inactive Ingredients anhydrous citric acid, sodium bicarbonate

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

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)

Pain reliever/fever reducer



*nonsteroidal anti-inflammatory drug

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Buffered aspirin 325 mg (NSAID)*

Section 60561-8 (60561-8)

Other information

each tablet contains: sodium 568 mg

● store at room temperature. Avoid excessive heat.

● Alka-Seltzer Pain Relief in water contains principally the analgesic sodium acetylsalicylate


Advanced Ingredient Data


Raw Label Data

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