Pseudoephedrine Extended-Release Tablets

What is this medication?

PSEUDOEPHEDRINE (soo doe e FED rin) treats a runny or stuffy nose. It may also be used to treat sinus congestion and pressure. It works by decreasing swelling in the nose, making it easier to breathe. It belongs to a group of medications called decongestants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Dimetapp Decongestant, Drixoral, Sudafed 12 Hour, Sudafed 24 Hour, Sudafed Sinus Congestion, Sudogest 12 Hour

What should I tell my care team before I take this medication?

They need to know if you have any of the following conditions:

• Bowel problems
• Diabetes
• Glaucoma
• Heart disease
• High blood pressure
• Kidney disease
• Prostate trouble
• Taken an MAOI, such as Carbex, Eldepryl, Marplan, Nardil, or Parnate in last 14 days
• Thyroid disease
• Trouble passing urine
• An unusual or allergic reaction to pseudoephedrine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the label. Do not cut, crush, or chew this medication. Do not take it more often than directed.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

People over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Bromocriptine
• Ergot alkaloids, such as dihydroergotamine, ergonovine, ergotamine, methylergonovine
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Stimulant medications for ADHD, weight loss, or staying awake

This medication may also interact with the following:

• Alcohol
• Atropine
• Bretylium
• Caffeine
• Certain heart medications, such as metoprolol
• Digoxin
• Linezolid
• Mecamylamine
• Medications for blood pressure
• Medications for depression, anxiety, or other mental health conditions, such as fluoxetine, sertraline
• Medications for enlarged prostate
• Medications that help you fall asleep
• Other medications for cold, cough, or allergy
• Procarbazine
• Reserpine
• St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your symptoms do not start to get better or if they get worse.

See your care team if you are not better in 7 days or if you have a fever.

If this medication makes it hard for you to sleep, try taking the dose earlier in the day. If you still have trouble sleeping, stop taking this medication and see your care team.

The tablet shell for some brands of this medication does not dissolve and may appear whole in the stool. This is not a cause for concern.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart palpitations—rapid, pounding, or irregular heartbeat
• Increase in blood pressure

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Anxiety, nervousness
• Headache
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 25 degrees C (59 and 77 degrees F). Protect from heat and moisture. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.