Aspirin, Citric Acid, Sodium Bicarbonate effervescent tablet
Drug Details
- Generic Name
- Aspirin, Citric Acid, Sodium Bicarbonate effervescent tablet
- Brand Names
- Alka-Seltzer
- Application Number
- M001
- Sponsor
- Lil' Drug Store Products, Inc.
- NDC Codes
- 1
- Dosage Forms
- TABLET, EFFERVESCENT
- Routes
- ORAL
- Active Ingredients
- ANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE
Indications and Usage
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
Warnings
Warnings 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. Allergy alert Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • asthma (wheezing) • shock 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 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.