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|Pediatex 12D Suspension

Pediatex 12D Suspension

Pediatex 12D Suspension is used for:

Relieving congestion, sneezing, and watery eyes due to colds, flu, or hay fever.

Pediatex 12D Suspension is an antihistamine and decongestant combination. It works by blocking the action of histamine and reducing the symptoms of an allergic reaction. It also relieves nasal congestion by causing vasoconstriction and shrinkage of the nasal mucous membranes and promoting drainage.

Do NOT use Pediatex 12D Suspension if:

• you are allergic to any ingredient in Pediatex 12D Suspension
• you have severe high blood pressure, severe heart disease (coronary artery disease, ischemic heart disease), severe breathing problems (eg, emphysema, chronic bronchitis), angle-closure glaucoma, or a peptic ulcer, or if you are unable to urinate due to bladder problems (urinary retention)
• you are having an asthma attack
• you are taking sodium oxybate (GHB), or if you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Pediatex 12D Suspension:

Some medical conditions may interact with Pediatex 12D Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have asthma; diabetes; heart disease; high blood pressure; increased inner eye pressure; phenylketonuria; a blockage of your stomach, intestines, or bladder; an overactive thyroid; difficulty urinating; an enlarged prostate; or seizures

Some MEDICINES MAY INTERACT with Pediatex 12D Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), furazolidone, MAO inhibitors (eg, phenelzine), tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, antacids) because side effects, such as increased drowsiness, headache, high blood pressure, or elevated body temperature, may occur
• Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and drowsiness leading to unconsciousness or coma, may occur
• Bromocriptine or droxidopa because the actions and side effects of these medicines may be increased by Pediatex 12D Suspension
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Pediatex 12D Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pediatex 12D Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Pediatex 12D Suspension:

Use Pediatex 12D Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pediatex 12D Suspension may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Shake well before each use.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Pediatex 12D Suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pediatex 12D Suspension.

Important safety information:

• Pediatex 12D Suspension may cause drowsiness, dizziness, or change in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Pediatex 12D Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Pediatex 12D Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• If you have trouble sleeping, ask your pharmacist or doctor about the best time of day to take Pediatex 12D Suspension.
• Do not take diet or appetite control medicines while you use Pediatex 12D Suspension unless your doctor tells you to.
• Pediatex 12D Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Pediatex 12D Suspension for a few days before the tests.
• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
• Pediatex 12D Suspension has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Use Pediatex 12D Suspension with caution in the ELDERLY; they may be more sensitive to its effects, especially sleeplessness.
• Caution is advised when using Pediatex 12D Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Pediatex 12D Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Pediatex 12D Suspension while you are pregnant. Pediatex 12D Suspension is found in breast milk. Do not breast-feed while taking Pediatex 12D Suspension.

Possible side effects of Pediatex 12D Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Appetite loss; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; headache; heartburn; nausea; nervousness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; double vision or other vision problems; fast or irregular heartbeat; frequent or painful urination; hallucinations; seizures; severe headache and dizziness; severe nervousness; tremor; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased mental alertness; fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sleeplessness; sweating; trouble breathing; unusual drowsiness or dizziness; tremors; vomiting.

Store Pediatex 12D Suspension at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Pediatex 12D Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Pediatex 12D Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Pediatex 12D Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Pediatex 12D Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.