Karbinal ER

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.

You may need to shake the oral suspension (liquid) before using. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of carbinoxamine can be fatal, especially to a child.

Overdose symptoms may include extreme drowsiness or restless feeling, dilated pupils, hallucinations, or seizure (convulsions).

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Avoid drinking alcohol. It may increase certain side effects of carbinoxamine.

Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Many combination medicines contain antihistamines. Taking certain products together can cause you to get too much of this type of medicine.

If you will be taking this medicine for a long time, it is very important that your doctor check you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate®.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and not able to think well.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates; muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• chills
• confusion
• cough
• decrease in the frequency of urination
• decrease in urine volume
• difficult or painful urination
• difficulty in passing urine (dribbling)
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, irregular, pounding, or racing heartbeat or pulse
• hives or welts
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• redness of the skin
• skin rash
• sweating
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Agitation
• anxiety
• bloating
• convulsions
• diarrhea
• difficulty with sleeping
• disorientation
• dizziness
• drowsiness to profound coma
• dry mouth
• feeling of warmth
• fixed and enlarged pupils
• gas
• headache
• lethargy
• lightheadedness
• loss of appetite
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• seeing, hearing, or feeling things that are not there
• stomach pain
• tightness of the chest
• trouble breathing
• vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Disturbed coordination
• drowsiness
• sleepiness

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough or hoarseness
• dark urine
• difficulty breathing
• difficulty having a bowel movement (stool)
• dizziness or lightheadedness
• double vision
• dry mouth, nose, and throat
• feeling excited
• feeling of constant movement of self or surroundings
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• headache
• hearing loss
• increased sensitivity of the skin to sunlight
• itching
• loss of appetite
• lower back or side pain
• nosebleeds
• pale skin
• pinpoint red spots on the skin
• redness or other discoloration of the skin
• restlessness
• seeing double
• seizures
• sensation of spinning
• severe sunburn
• shakiness in the legs, arms, hands, or feet
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• trembling or shaking of the hands or feet
• trouble sleeping
• unusual bleeding or bruising
• weight loss
• yellowing of the eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Karbinal ER Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of:

• Seasonal and perennial allergic rhinitis
• Vasomotor rhinitis
• Allergic conjunctivitis due to inhalant allergens and foods
• Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
• Dermatographism
• As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
• Amelioration of the severity of allergic reactions to blood or plasma

Extended-release oral suspension containing 4 mg carbinoxamine maleate per 5 mL

Use of Karbinal ER is contraindicated in patients who are taking monoamine oxidase inhibitors (MAOIs), which prolong and intensify the anticholinergic (drying) effects of antihistamines.

Avoid use of Karbinal ER with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) due to additive effects.

Karbinal ER contains 4 mg carbinoxamine maleate per 5 mL. It is a light beige to tan viscous suspension with strawberry banana flavor and is supplied as follows:

NDC 13551-101-05 Bottles of 16 fl oz (480 mL)
NDC 13551-101-01 Bottles of 1 fl oz (30 mL) Physician Samples

Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Dispense in tight, light-resistant container with child-resistant closure.

. Dosing

Advise patients to measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. [see Dosage and Administration (2)].

. Activities Requiring Mental Alertness

Advise patients to use caution when driving a motor vehicle or operating machinery. Karbinal ER may produce marked drowsiness and impair the mental or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery [see Warnings and Precautions (5.2)].

. Alcohol, Sedatives, and Tranquilizers

Advise patients to avoid the use of alcoholic beverages, sedatives, and tranquilizers while taking Karbinal ER because additional reduction in mental alertness may occur [see Warnings and Precautions (5.2) and Drug Interactions (7)].

. MAOIs

Advise patients to not use MAOIs while taking Karbinal ER. MAOIs may prolong and intensify the anticholinergic (drying) effects [see Contraindications (4.4) and Drug Interactions (7)].

Distributed by:

Avadel

Avadel Pharmaceuticals (USA), Inc.
Chesterfield, MO 63005
www.avadel.com

Manufactured by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852

LB8056
Rev 01
03/17

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

NDC 13551-101-05

Karbinal™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
16 fl oz (480 mL)

PRINCIPAL DISPLAY PANEL - 480 mL Alternate Bottle Label

NDC 13551-101-05

Karbinal™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
16 fl oz (480 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 13551-101-01

Karbinal™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
1 fl oz (30 mL)

Physician Sample Not For Sale

PRINCIPAL DISPLAY PANEL - 30 mL Carton Label

NDC 13551-101-01

Karbinal™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
Two 1 fl oz (30 mL)

PHYSICIAN SAMPLES - NOT FOR SALE

PRINCIPAL DISPLAY PANEL - 480 mL Alternate Bottle Label (FSC Laboratories)

NDC 13551-101-05

Karbinal™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
16 fl oz (480 mL)

PRINCIPAL DISPLAY PANEL - 30 mL Alternate Carton Label (FSC Laboratories)

NDC 13551-101-01

Karbinal™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx Only
Two 1 fl oz (30 mL)

Physician Samples - Not for Sale