Alka-Seltzer Original

Alka-Seltzer Original is an FDA-registered drug product whose active ingredient is ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE. It is labelled by Select Consumer Group taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85237-1829, application M013, label effective 20260524. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE are most often described in connection with: headache body, temporary relief, heartburn acid, sour stomach, pains upset, overindulgence food, pain alone. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Directions Directions ● fully dissolve 2 tablets in 4 ounces of water before taking 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 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 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 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 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 When using this product do not exceed recommended dosage 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 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Alka-Seltzer Original used for?
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

Who makes Alka-Seltzer Original?
Select Consumer Group is the labeler of record for Alka-Seltzer Original.

What form does Alka-Seltzer Original come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Alka-Seltzer Original prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Alka-Seltzer Original been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.