ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE

FDA Drug Profile — Alka Seltzer Originial 1s Blister Pack, Alka-Seltzer Original, Alka-Seltzer Hangover Relief, Alka-Seltzer Heartburn and Pain

Drug Details

Generic Name
ANHYDROUS CITRIC ACID, ASPIRIN, and SODIUM BICARBONATE
Brand Names
Alka Seltzer Originial 1s Blister Pack, Alka-Seltzer Original, Alka-Seltzer Hangover Relief, Alka-Seltzer Heartburn and Pain
Application Number
M013
Sponsor
JC World Bell Wholesale Co., Inc.
NDC Codes
6
Dosage Forms
TABLET, EFFERVESCENT
Routes
ORAL
Active Ingredients
ANHYDROUS CITRIC ACID, ASPIRIN, SODIUM BICARBONATE, CAFFEINE

Indications and Usage

Uses For the temporary relief of minor aches and pains with heartburn, sour stomach, or acid indigestion and upset stomach associated with these symptoms for temporary relief of headaches, body aches, backache and pain alone

Warnings

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. Do not use if you have ever had an allergic reaction to 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 take more than the maximum daily dosage in a 24-hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician. 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 ringing in the ears or a loss of hearing occurs pain get worse or last more than 10 days redness or swelling is present any new symptoms appear 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. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.