Drug Facts
Drug Facts
Alka-seltzer Gold Tablet, Effervescent
FDA Label NDC 0280-4100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bayer Healthcare Llc. for the product Alka-seltzer Gold (NDC 0280-4100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, indications & usage, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Anhydrous citric acid 1000 mg.................................………Antacid
Potassium bicarbonate 344 mg.…..………………….……..Antacid
Sodium bicarbonate (heat-treated) 1050 mg………………Antacid
Purpose
Antacid
Indications & Usage
Uses for the relief of
● heartburn ● acid indigestion ● sour stomach
Do Not Use
Do not use if you have ever had an allergic reaction to this product or any of its ingredients
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.
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children.
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 |
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
Inactive Ingredients
Inactive ingredients magnesium stearate, mannitol
Questions Or Comments
Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)
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
* Please review the disclaimer below.
