"Jan. 18, 2011 -- McNeil Consumer Healthcare, which makes Tylenol pain relief drugs, says it is recalling a number of lots of its Tylenol products as well as some lots of Sinutab, Benadryl, and Sudafed PE because the medications were made at a pla"...
Sudafed Patient Information Including Side Effects
Brand Names: Chlor Trimeton Nasal Decongestant, Contac Cold, Drixoral Decongestant Non-Drowsy, Elixsure Decongestant, Entex, Genaphed, Kid Kare Drops, nasofed, Seudotabs, Silfedrine, Sudafed, Sudafed 12-Hour, Sudafed 24-Hour, Sudafed Children's Nasal Decongestant, Sudodrin, SudoGest, SudoGest 12 Hour, Suphedrin, Triaminic Softchews Allergy Congestion, Unifed
Generic Name: pseudoephedrine (Pronunciation: SOO doe ee FED rin)
- What is pseudoephedrine (Sudafed)?
- What are the possible side effects of pseudoephedrine?
- What is the most important information I should know about pseudoephedrine?
- What should I discuss with my healthcare provider before taking pseudoephedrine?
- How should I take pseudoephedrine?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking pseudoephedrine?
- What other drugs will affect pseudoephedrine?
- Where can I get more information?
What is pseudoephedrine (Sudafed)?
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
Pseudoephedrine is used to treat nasal and sinus congestion, or congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.
Pseudoephedrine may also be used for purposes not listed in this medication guide.
Pseudoephedrine 30 mg-ROX
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Pseudoephedrine 60 mg-ROX
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What are the possible side effects of 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 pseudoephedrine and call your doctor at once if you have a serious side effect such as:
- fast, pounding, or uneven heartbeat;
- severe dizziness or anxiety;
- easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
- dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).
Less serious side effects may include:
- loss of appetite;
- warmth, tingling, or redness under your skin;
- feeling restless or excited (especially in children);
- sleep problems (insomnia); or
- skin rash or itching.
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.
Read the Sudafed (pseudoephedrine) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about 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 and cold medicines in very young children.
Ask a doctor or pharmacist before using any other cough or cold medicine. Pseudoephedrine or other decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains pseudoephedrine or a decongestant.
Do not use pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.
Additional Sudafed Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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