FDA Label for Alka-seltzer Heartburn And Pain

Other

Drug Facts

Dist. by: Bayer HealthCare LLC

Whippany, NJ 07981

Otc - Purpose

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

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

Otc - When Using

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
  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

Directions

● Completely dissolve 2 tablets in 4 ounces of water and be sure bubbling has stopped before drinking

● Do not exceed recommended dose. SEE WARNINGS

Other Information

• each tablet contains: sodium 568 mg
• store at room temperature. Avoid excessive heat.
• Alka-Seltzer Heartburn + Pain in water contains principally the antacid sodium citrate and the analgesic sodium acetylsalicylate

Inactive Ingredients

none

Questions Or Comments?

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