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|Baby"s Own Infant Drops

SIMETHICONE (Oral)

Some commonly used brand names are:

In the U.S.—

• Extra Strength Maalox Anti-Gas
• Flatulex
• Gas Relief
• Gas-X
• Gas-X Extra Strength
• Genasyme
• Maalox Anti-Gas
• Maximum Strength Gas Relief
• Maximum Strength Mylanta Gas Relief
• Maximum Strength Phazyme
• My Baby Gas Relief Drops
• Mylanta Gas
• Mylanta Gas Relief
• Mylicon Drops
• Phazyme
• Phazyme-95

In Canada—

• Extra Strength Maalox GRF Gas Relief Formula
• Baby"s Own Infant Drops
• Maalox GRF Gas Relief Formula
• Ovol
• Ovol-40
• Ovol-80
• Ovol-160
• Phazyme Drops
• Phazyme-95
• Phazyme-125

Generic name product may be available in the U.S.

Category

• Antiflatulent
• Diagnostic aid, gastroscopy
• Diagnostic aid, radiography of the bowel

Description

Simethicone (si-METH-i-kone) is used to relieve the painful symptoms of too much gas in the stomach and intestines.

Simethicone may also be used for other conditions as determined by your doctor.

Simethicone is available without a prescription; however, your doctor may have special instructions on the proper use and dose for your medical problem. It is available in the following dosage forms:

• Oral
• Capsules (U.S. and Canada)
• Oral suspension (U.S. and Canada)
• Tablets (U.S.)
• Chewable tablets (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For simethicone, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to simethicone. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Simethicone is not absorbed into the body and is not likely to cause problems.

Breast-feeding—Simethicone has not been reported to cause problems in nursing babies.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of simethicone in the elderly with use in other age groups.

Proper Use of This Medicine

For effective use of simethicone:

• Follow your doctor"s instructions if this medicine was prescribed.
• Follow the manufacturer"s package directions if you are treating yourself.

Take this medicine after meals and at bedtime for best results .

For patients taking the chewable tablet form of this medicine:

• It is important that you chew the tablets thoroughly before you swallow them. This is to allow the medicine to work faster and more completely.

For patients taking the oral liquid form of this medicine:

• This medicine is to be taken by mouth even if it comes in a dropper bottle. The amount you should take is to be measured with the specially marked dropper or measuring spoon.

Avoid foods that seem to increase gas. Chew food thoroughly and slowly. Reduce air swallowing by avoiding fizzy, carbonated drinks. Do not smoke before meals. Develop regular bowel habits and exercise regularly. Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient.

Dosing—The dose of simethicone will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of simethicone. If your dose is different, do not change it unless your doctor tells you to do so.

• For symptoms of too much gas:
  • For oral dosage forms (capsules or tablets):
    • Adults and teenagers—Usual dose is 60 to 125 milligrams (mg) four times a day, after meals and at bedtime. The dose should not be more than 500 mg in twenty-four hours.
    • Children—Dose must be determined by the doctor.
  • For oral dosage form (chewable tablets):
    • Adults and teenagers—Usual dose is 40 to 125 mg four times a day, after meals and at bedtime or the dose may be 150 mg three times a day, after meals. The dose should not be more than 500 mg in twenty-four hours.
    • Children—Dose must be determined by the doctor.
  • For oral dosage form (suspension):
    • Adults and teenagers—Usual dose is 40 to 95 mg four times a day, after meals and at bedtime. The dose should not be more than 500 mg in twenty-four hours.
    • Children—Dose must be determined by the doctor.

Missed dose—If you must take this medicine regularly and you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Side Effects of This Medicine

There have not been any common or important side effects reported with this medicine. However, if you notice any side effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, simethicone is used in certain patients before the following tests:

• Before a gastroscopy
• Before a radiography of the bowel

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 08/14/1998

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