FDA Label for Alka Seltzer Original

View Indications, Usage & Precautions

Alka Seltzer Original Product Label

The following document was submitted to the FDA by the labeler of this product Navajo Manufacturing Company Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each Tablet)



Anhydrous citric acid 1000 mg

Aspirin 325 mg (NSAID)*

Sodium bicarbonate (heat-treated) 1916 mg

*nonsteroidal anti-inflammatory drug


Purposes



Antacid

Analgesic


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



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.


Directions



fully dissolve 2 tablets in 4 ounces of water before taking

 adults and children       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


Other Information



• do not use if pouch is opened
• each tablet contains: sodium 567 mg
• store at room temperature. Avoid excessive heat.
• Alka-Seltzer® in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate


Inactive Ingredients



Water


Questions Or Comments?



1-800-986-0369 (Mon - Fri 9AM - 5PM EST) or www.alkaseltzer.com


* Please review the disclaimer below.