Comfort Gel

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Take this medication by mouth, usually after meals and at bedtime as needed. Follow all the directions on the product package or use as directed by your doctor. If you have any questions, ask your doctor or pharmacist.

If you are taking the chewable tablets, chew thoroughly before swallowing, then drink a full glass of water (8 ounces or 240 milliliters).

If you are using the liquid form of this medication, shake the bottle well before pouring each dose. Measure the dose out carefully using a medication spoon/cup. Do not use a household spoon because you may not get the right dose. Refrigerating the suspension may improve the flavor. Do not freeze. The liquid form works best if taken without other fluids. You can mix your dose with a little water if needed.

This product may react with other medications (including digoxin, iron, pazopanib, tetracycline antibiotics, quinolone antibiotics such as ciprofloxacin), preventing them from being fully absorbed by your body. Talk with your doctor or pharmacist about how to schedule your medications to prevent this problem.

If your acid problems last or get worse after you have used this product for 1 week, or if you think you have a serious medical problem, get medical help right away. If you are using this medication regularly on a daily basis for more than 2 weeks, you may have a medical problem that needs different treatment. Ask your doctor whether this is the right medication for you.

Nausea, constipation, diarrhea, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

The magnesium in this product can cause diarrhea. Using an antacid that contains only aluminum along with this product can help control diarrhea. The aluminum in this product can cause constipation. To minimize constipation, drink plenty of fluids and exercise. Diarrhea is more common with this product than constipation.

If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Aluminum-containing antacids bind to phosphate, an important body chemical, in the gut. This can cause low phosphate levels, especially if you use this medication in large doses and for a long time. Tell your doctor right away if you have any of the following symptoms of low phosphate: loss of appetite, unusual tiredness, muscle weakness.

Tell your doctor right away if you have any serious side effects, including: dizziness, fainting.

Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, slow/irregular heartbeat, mental/mood changes (such as confusion), deep sleep, pain with urination.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to aluminum hydroxide; or to magnesium; or to simethicone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

If you have any of the following health problems, consult your doctor or pharmacist before using this product: frequent alcohol use, dehydration/fluid restriction, kidney problems (including kidney stones).

This medicine may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

This medicine may contain sugar. If you have diabetes, consult your doctor or pharmacist about using this drug safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: phosphate supplements (such as potassium phosphate), sodium polystyrene sulfonate.

Antacids can interfere with the absorption of many other drugs. Be sure to check with your pharmacist before taking antacids with any other medication.

Keep all medical and lab appointments.

Lifestyle changes such as stress reduction programs, stopping smoking, limiting alcohol, and diet changes (such as avoiding caffeine, fatty foods, certain spices) may increase the effectiveness of this medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. The liquid product may be stored in the refrigerator to improve taste. Do not freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.