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|Nite-Time Cold/Flu

Nite-Time Cold/Flu

Nite-Time Cold/Flu is used for:

Relieving symptoms of pain, sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

Nite-Time Cold/Flu is a decongestant, antihistamine, cough suppressant, and analgesic combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce dry or unproductive cough.

Do NOT use Nite-Time Cold/Flu if:

• you are allergic to any ingredient in Nite-Time Cold/Flu
• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
• you are unable to urinate or are having an asthma attack
• you take sodium oxybate (GHB) or 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 Nite-Time Cold/Flu :

Some medical conditions may interact with Nite-Time Cold/Flu . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 a fast, slow, or irregular heartbeat
• if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; an overactive thyroid; or liver problems; or if you consume more than 3 alcohol-containing drinks per day
• if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Nite-Time Cold/Flu . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), COMT inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAO inhibitors (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects of Nite-Time Cold/Flu may be increased
• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat or heart attack may be increased
• Bromocriptine or hydantoins (eg, phenytoin) because side effects may be increased by Nite-Time Cold/Flu
• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because effectiveness may be decreased by Nite-Time Cold/Flu

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nite-Time Cold/Flu 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 Nite-Time Cold/Flu :

Use Nite-Time Cold/Flu as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nite-Time Cold/Flu may be taken with or without food.
• If you miss a dose of Nite-Time Cold/Flu , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Nite-Time Cold/Flu .

Important safety information:

• Nite-Time Cold/Flu may cause dizziness, drowsiness, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Nite-Time Cold/Flu . Using this medicine alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not take diet or appetite control medicines while you are taking Nite-Time Cold/Flu without checking with your doctor.
• Nite-Time Cold/Flu contains acetaminophen and pseudoephedrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or pseudoephedrine. If it does or if you are uncertain, contact your doctor or pharmacist.
• Do NOT exceed the recommended dose or take Nite-Time Cold/Flu for longer than prescribed without checking with your doctor.
• If your symptoms do not improve within 5 to 7 days or if they become worse, check with your doctor.
• Nite-Time Cold/Flu may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Nite-Time Cold/Flu . Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Nite-Time Cold/Flu may cause liver damage. If you consume 3 or more alcohol-containing drinks every day, ask your doctor if you should take Nite-Time Cold/Flu or other pain relievers/fever reducers. Alcohol use combined with Nite-Time Cold/Flu may increase your risk for liver damage.
• If you are scheduled for allergy skin testing, do not take Nite-Time Cold/Flu for several days before the test because it may decrease your response to the skin tests.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Nite-Time Cold/Flu .
• Use Nite-Time Cold/Flu with caution in the ELDERLY because they may be more sensitive to its effects.
• Caution is advised when using Nite-Time Cold/Flu in CHILDREN because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Nite-Time Cold/Flu , discuss with your doctor the benefits and risks of using Nite-Time Cold/Flu during pregnancy. It is unknown if Nite-Time Cold/Flu is excreted in breast milk. Do not breast-feed while taking Nite-Time Cold/Flu .

Possible side effects of Nite-Time Cold/Flu :

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:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; stomach pain; tremor; trouble sleeping; vision changes; yellowing of skin or eyes.

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. 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Store Nite-Time Cold/Flu at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep this medicine out of the reach of children and away from pets.

General information:

• If you have any questions about Nite-Time Cold/Flu , please talk with your doctor, pharmacist, or other health care provider.
• Nite-Time Cold/Flu 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 Nite-Time Cold/Flu . 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.