What is acetaminophen, clemastine, and pseudoephedrine?
Acetaminophen is a pain reliever and fever reducer.
Clemastine is an antihistamine that reduces the natural chemical histamine in the body.
Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated
blood vessels can cause nasal congestion (stuffy nose).
The combination of acetaminophen, clemastine, and pseudoephedrine is used to treat runny or
stuffy nose, sinus congestion, sneezing, and pain or fever caused by allergies or the common cold.
Acetaminophen, clemastine, and pseudoephedrine may also be used for other purposes not
listed in this medication guide.
What should I discuss with my healthcare provider before taking acetaminophen, clemastine, and pseudoephedrine?
Do not use this medication if you have used an MAO inhibitor such as isocarboxazid
(Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine
(Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a
decongestant before the MAO inhibitor has cleared from your body.
Do not take this medication if you are allergic to acetaminophen, clemastine, or
pseudoephedrine, or to other antihistamines or decongestants, diet pills, stimulants, or ADHD
medications.
If you have any of these other conditions, you may need a dose adjustment or special tests to
safely take acetaminophen, clemastine, and pseudoephedrine:
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heart disease or high blood pressure;
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liver disease, alcoholism, or cirrhosis of the liver;
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glaucoma;
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kidney disease;
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diabetes;
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a thyroid disorder;
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an enlarged prostate; or
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problems with urination.
It is not known whether this medication is harmful to an unborn baby.
Before taking acetaminophen, clemastine, and pseudoephedrine, tell your doctor if you are pregnant or
plan to become pregnant during treatment.
It is not known whether acetaminophen, clemastine, and pseudoephedrine may pass into
breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if
you are breast-feeding a baby.
How should I take acetaminophen, clemastine, and pseudoephedrine?
Use this medication exactly as directed on the label, or as it has been prescribed by your
doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold
medicine should be taken only for a short time until your symptoms clear up.
Take this medication with food or milk if it upsets your stomach.
Drink extra fluids while you are taking acetaminophen, clemastine, and pseudoephedrine.
An overdose of acetaminophen can cause serious harm. The maximum amount of
acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more
acetaminophen could cause damage to your liver. One acetaminophen, clemastine, and
pseudoephedrine tablet contains 325 mg of acetaminophen. Know the amount of acetaminophen in the
specific product you are taking.
Do not give this medication to a child younger than 4 years old.
Always ask a
doctor before giving cough or cold medicine to a child.
Death can occur from the misuse
of cough or cold medicine in very young children.
Talk with 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.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor
who treats you that you are taking an antihistamine.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold
medicine within the past few days.
Store this medication at room temperature, away from heat, light, and moisture.
What happens if I miss a dose of acetaminophen, clemastine, and pseudoephedrine?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the
missed dose and take the medicine at your next regularly scheduled time.
Do not
take
extra medicine to make up the missed dose.
Where can I get more information about acetaminophen, clemastine, and pseudoephedrine?
Your pharmacist has information about acetaminophen, clemastine, and pseudoephedrine written for health professionals that you may read.
What are the possible side effects of acetaminophen, clemastine, and pseudoephedrine?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side
effects:
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fast, pounding, or uneven heartbeat;
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confusion, hallucinations, unusual thoughts or behavior;
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severe dizziness, anxiety, restless feeling, or nervousness;
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dangerously high blood pressure (severe headache, blurred
vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven
heartbeats, seizure);
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urinating less than usual or not at all;
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easy bruising or bleeding, unusual weakness, fever, chills,
body aches, flu symptoms; or
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nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
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dry mouth;
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mild nausea or loss of appetite;
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constipation;
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dizziness, drowsiness;
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problems with memory or concentration;
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ringing in your ears;
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feeling restless or excited (especially in children);
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sleep problems (insomnia);
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mild skin rash or itching; or
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warmth, tingling, or redness under your skin.
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.
What is the most important information I should know about acetaminophen, clemastine, and pseudoephedrine?
Do not give this medication to a child younger than 4 years old.
Always ask a
doctor before giving a cough or cold medicine to a child.
Death can occur from the
misuse of cough or cold medicine in very young children.
Do not use this medication if you have used an MAO inhibitor such as isocarboxazid
(Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine
(Parnate) within the past 14 days.
Do not take more of this medication than is recommended. An overdose of acetaminophen
can cause damage to your liver.
Do not use any other cough, cold, allergy, or pain medication without first asking your
doctor or pharmacist. If you take certain products together you may accidentally take too much of a
certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen
(sometimes abbreviated as "APAP"), clemastine, or pseudoephedrine.
Avoid drinking alcohol. It can increase the risk of liver damage while you are taking
acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen
without your doctor's advice, and never take more than 2 grams (2000 mg) per day.
What should I avoid while taking acetaminophen, clemastine, and pseudoephedrine?
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without
your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of
unpleasant side effects.
Do not use any other cough, cold, allergy, or pain medication without first asking your
doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") and pseudoephedrine are
contained in many combination medicines. If you take certain products together you may accidentally
take too much of a certain drug. Read the label of any other medicine you are using to see if it contains
acetaminophen, APAP, clemastine or pseudoephedrine.
Avoid drinking alcohol. It can increase the risk of liver damage while you are taking
acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen
without your doctor's advice, and never take more than 2 grams (2000 mg) per day.
This medication can cause side effects that may impair your thinking or reactions. Be
careful if you drive or do anything that requires you to be awake and alert.
Avoid becoming overheated or dehydrated during exercise and in hot weather.
What other drugs will affect acetaminophen, clemastine, and pseudoephedrine?
Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures,
depression or anxiety can add to sleepiness caused by clemastine. Tell your doctor if you regularly use
any of these medicines, or any other cold or allergy medicine.
Tell your doctor about all other medications you use, especially:
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an antidepressant;
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a bronchodilator;
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a diuretic (water pill);
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gout medications;
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blood pressure medication;
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medication to treat irritable bowel syndrome;
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bladder or urinary medications such as oxybutynin
(Ditropan, Oxytrol) or tolterodine (Detrol);
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seizure medication;
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isoniazid;
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zidovudine (Retrovir, AZT);
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aspirin or salicylates (such as Disalcid, Doan's Pills,
Dolobid, Salflex, Tricosal, and others); or
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a beta-blocker such as atenolol (Tenormin), carteolol
(Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), propranolol
(Inderal), sotalol (Betapace), timolol (Blocadren), and others.
This list is not complete and there may be other drugs that can interact with
acetaminophen, clemastine, and pseudoephedrine. Tell your doctor about all the prescription and
over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs
prescribed by other doctors. Do not start using a new medication without telling your doctor.
What happens if I have an overdose of acetaminophen, clemastine, and pseudoephedrine?
