Alka-seltzer Gold

SPL v9

SPL

SPL Set ID 0824bedb-413b-2fa0-e054-00144ff88e88

Route

ORAL

Published

Effective Date 2014-11-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Anhydrous Citric Acid (1000 mg) Potassium Cation (344 mg) Sodium Cation (1050 mg)

Inactive Ingredients

Magnesium Stearate Mannitol

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 25 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-11-19

Description

Drug Facts

Purpose

Antacid

Medication Information

Warnings and Precautions

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

Indications and Usage

Uses for the relief of

● heartburn ● acid indigestion ● sour stomach

Purpose

Antacid

Description

Drug Facts

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

● fully dissolve tablets in 4 ounces of water before taking

adults and children 12 years and over	2 tablets every 4 hours as needed, or asdirected by a doctor	do not exceed8 tablets in 24 hours
adults 60 years and over	2 tablets every 4 hours as needed, or as directed by a doctor	do not exceed 6 tablets in 24 hours
children under 12 years	1 tablet every 4 hours as needed, or as directed by a doctor	do not exceed 4 tablets in 24 hours

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Drug Facts

Drug Facts

Other Information

● each tablet contains: potassium 135 mg

● each tablet contains: sodium 309 mg

● store at room temperature. Avoid excessive heat.

● this product does not contain aspirin

● Alka-Seltzer Gold in water contains principally the

antacids sodium citrate and potassium citrate

Active Ingredients

Anhydrous citric acid 1000 mg.................................………Antacid

Potassium bicarbonate 344 mg.…..………………….……..Antacid

Sodium bicarbonate (heat-treated) 1050 mg………………Antacid

Inactive Ingredients

Inactive ingredients magnesium stearate, mannitol

Questions Or Comments

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

When Using This Product

When using this product do not exceed recommended dosage

Stop Use and Ask A Doctor If

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

Keep Out of Reach of Children

Keep out of reach of children.

Ask A Doctor Before Use If You Have

kidney disease
a potassium or sodium-restricted diet

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.

Structured Label Content

Indications and Usage (34067-9)

Uses for the relief of

● heartburn ● acid indigestion ● sour stomach

Warnings and Precautions (34071-1)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Antacid

Directions

● fully dissolve tablets in 4 ounces of water before taking

adults and children 12 years and over	2 tablets every 4 hours as needed, or asdirected by a doctor	do not exceed8 tablets in 24 hours
adults 60 years and over	2 tablets every 4 hours as needed, or as directed by a doctor	do not exceed 6 tablets in 24 hours
children under 12 years	1 tablet every 4 hours as needed, or as directed by a doctor	do not exceed 4 tablets in 24 hours

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Drug Facts

Drug Facts

Other Information (Other information)

● each tablet contains: potassium 135 mg

● each tablet contains: sodium 309 mg

● store at room temperature. Avoid excessive heat.

● this product does not contain aspirin

● Alka-Seltzer Gold in water contains principally the

antacids sodium citrate and potassium citrate

Active Ingredients

Anhydrous citric acid 1000 mg.................................………Antacid

Potassium bicarbonate 344 mg.…..………………….……..Antacid

Sodium bicarbonate (heat-treated) 1050 mg………………Antacid

Inactive Ingredients (Inactive ingredients)

Inactive ingredients magnesium stearate, mannitol

Questions Or Comments (Questions or comments)

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

When Using This Product (When using this product)

When using this product do not exceed recommended dosage

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Stop use and ask a doctor if you have taken the maximum dose for 2 weeks

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

kidney disease
a potassium or sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are (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.

Advanced Ingredient Data

[{"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "ACTIM", "strengthNumerator": "1000", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "POTASSIUM CATION", "unii": "295O53K152", "classCode": "ACTIM", "strengthNumerator": "344", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SODIUM CATION", "unii": "LYR4M0NH37", "classCode": "ACTIB", "strengthNumerator": "1050", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses for the relief of ● heartburn ● acid indigestion ● sour stomach", "34071-1": "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Antacid", "Directions": "● fully dissolve tablets in 4 ounces of water before taking adults and children 12 years and over 2 tablets every 4 hours as needed, or asdirected by a doctor do not exceed8 tablets in 24 hours adults 60 years and over 2 tablets every 4 hours as needed, or as directed by a doctor do not exceed 6 tablets in 24 hours children under 12 years 1 tablet every 4 hours as needed, or as directed by a doctor do not exceed 4 tablets in 24 hours", "Do Not Use": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients", "Drug Facts": "Drug Facts", "Other information": "● each tablet contains: potassium 135 mg ● each tablet contains: sodium 309 mg ● store at room temperature. Avoid excessive heat. ● this product does not contain aspirin ● Alka-Seltzer Gold in water contains principally the antacids sodium citrate and potassium citrate", "Active Ingredients": "Anhydrous citric acid 1000 mg.................................………Antacid Potassium bicarbonate 344 mg.…..………………….……..Antacid Sodium bicarbonate (heat-treated) 1050 mg………………Antacid", "Inactive ingredients": "Inactive ingredients magnesium stearate, mannitol", "Questions or comments": "Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)", "When using this product": "When using this product do not exceed recommended dosage", "Stop use and ask a doctor if": "Stop use and ask a doctor if you have taken the maximum dose for 2 weeks", "Keep out of reach of children": "Keep out of reach of children.", "Ask a doctor before use if you have": "kidney disease a potassium or sodium-restricted diet", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:27.246715 · Updated: 2026-03-14T23:10:55.855807