The U.S. Food and Drug Administration (FDA) is warning that use of nonsteroidal anti-inflammatory drugs (NSAIDs) around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby.

Magnesium salicylate is approved by FDA and is safe and effective when used according to the Drug Facts label. You should not take more medicine or for a longer period of time than the label says unless instructed by a healthcare provider.

Ask a healthcare provider before use if:

• You drink more than three or more alcoholic drinks a day.
• You are currently using a medicine containing a prescription or nonprescription NSAID (e.g., aspirin, naproxen sodium, ibuprofen, or others).
• You have stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain; ulcers; or bleeding problems.
• You have asthma.
• You are taking a prescription blood thinner (anticoagulant), steroid drug, or a prescription medicine for gout, diabetes, or arthritis.
• You have high blood pressure, heart disease, liver cirrhosis, or kidney disease.
• You are taking a diuretic.
• You are pregnant or breastfeeding. Women in the last three months of pregnancy are specifically told not to use aspirin or any other NSAID (e.g., aspirin, naproxen sodium, ibuprofen, or others) without a healthcare provider’s permission.

Do not use if:

• You are allergic to salicylates (including aspirin) or any other pain reliever/fever reducer.
• You are a woman in the last three months of pregnancy unless your healthcare provider specifically tells you to. Problems in the unborn child or complications during delivery may occur.
• Tamper-evident packaging features such as seals, locks, and films are not clear or seem broken.
• Do not give an OTC medicine containing magnesium salicylate to children under the age of 12 unless advised by a healthcare provider.
• Your child or teenager has or is recovering from the chicken pox or flu due to a rare illness (Reye's syndrome) reported to be associated with magnesium salicylate.

Stop use and ask a doctor if:

• An allergic reaction occurs. Seek medical help right away.
• Your fever gets worse or lasts more than three days, or if your pain gets worse and lasts more than 10 days.
• You have signs of stomach bleeding, such as if you feel faint, vomit blood, have stomach pain or upset that lasts or does not get better, or if you have bloody or black stools.
• Redness or swelling is present in the painful area or if any new symptoms appear.
• You hear ringing in your ears or you begin to lose your hearing.
• You take too much. Immediately contact a healthcare provider or the poison control national helpline at 800.222.1222.

What are the side effects of magnesium salicylate?

• Magnesium salicylate, like other NSAIDs, may cause a severe allergic reaction. Symptoms can include hives, facial swelling, asthma (wheezing), and shock.
• Stomach bleeding may occur.