Trexbrom

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• painful or difficult urination;
• little or no urinating;
• chest tightness, pounding heartbeats or fluttering in your chest;
• seizure (convulsions);
• pale or yellowed skin, dark colored urine; or
• sudden weakness or ill feeling, fever, red or swollen gums, easy bruising, unusual bleeding.

Common side effects may include:

• drowsiness, dizziness;
• nausea, constipation, diarrhea;
• dryness of the nose, mouth, or throat;
• blurred vision; or
• feeling restless or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to any part of Trexbrom (phenylephrine/brompheniramine/chlophedianol liquid).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson's disease like selegiline or rasagiline in the last 14 days. Taking this medicine within 14 days of those drugs can cause very bad high blood pressure.
• If you have a cough with a lot of mucous.
• If you have a long-term cough caused by smoking or being around smoke, or lung problems like asthma or emphysema.

This is not a list of all drugs or health problems that interact with Trexbrom.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take Trexbrom. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Trexbrom affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Trexbrom while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Each teaspoonful (5mL) contains:

Carbetapentane

Citrate . . . . . . . . . . . . . 30 mg

Phenylephrine HCl . . . . . 10 mg

Brompheniramine

Maleate . . . . . . . . . . . . . 6 mg

Trexbrom( Liquid is a clear, sugar free, alcohol free, bubble gum flavored liquid. Available in 10 mL sample bottles (NDC 64543-500-10), 4 oz. Bottles (NDC 64543-500-04), and 16 oz. Bottles (NDC 64543-500-16).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN

CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage and Handling

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Store at controlled room temperature, 20°- 25°C (68°- 77°F), See USP Controlled Room Temperature.

Call Your Doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

Rx Only

Manufactured for:

Capellon Pharmaceuticals, LLC

Fort Worth, TX 76118

500391  Rev. 09/09

Figure 1: Trexbrom 10 mL sample label

Figure 2: Trexbrom 4 oz product label

Figure 3: Trexbrom 16 oz. product label

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling nervous and excitable.
• Not able to sleep.
• Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Trexbrom may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.