Efidac 24 Pseudoephedrine (Oral)

Pseudoephedrine helps to relieve nasal or sinus congestion caused by the common cold, sinusitis, hay fever, and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.

Some of these products are available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects.

If your symptoms do not get better within 7 days or if you also have a high fever, contact your doctor because these signs may indicate that you have other medical issues.

In choosing to use a medicine, you and your doctor need to consider the risks versus the benefits. Here are important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Pseudoephedrine may cause more side effects in infants, especially newborns and premature infants, than in older children and adults.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years old. These medicines can cause serious or possibly life-threatening side effects in very young children.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it is unclear whether they work the same way as they do in younger adults or if they cause different side effects or issues in older individuals. There is no specific information about using pseudoephedrine in elderly patients compared to other age groups.

Breast Feeding

There are no adequate studies in women to determine if there is any risk to infants when using this medication while breastfeeding. Consider the potential benefits versus the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction could occur. Your doctor may want to adjust doses or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

It is not recommended to use this medicine with any of the following:

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following is usually not recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both of the medicines.

• Guanethidine
• Iobenguane I 123
• Iobenguane I 131
• Methyldopa
• Midodrine
• Zavegepant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtimes, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are significant but may not include all possible interactions.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical conditions, especially:

• Type 2 diabetes mellitus—Using pseudoephedrine may raise blood glucose levels.

• Enlarged prostate or
• Glaucoma, or a risk of glaucoma or
• Heart disease or blood vessel disease or
• High blood pressure—Pseudoephedrine may worsen these conditions.

• Overactive thyroid—Using pseudoephedrine may worsen this condition.

Along with its needed effects, a medicine may also cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

more common with high doses

• Convulsions (seizures)
• hallucinations (seeing, hearing, or feeling things that are not there)
• irregular or slow heartbeat
• shortness of breath or troubled breathing

Symptoms of overdose

• Convulsions (seizures)
• fast breathing
• hallucinations (seeing, hearing, or feeling things that are not there)
• increase in blood pressure
• irregular heartbeat (continuing)
• shortness of breath or troubled breathing (severe or continuing)
• slow or fast heartbeat (severe or continuing)
• unusual nervousness, restlessness, or excitement

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

More common

• Nervousness
• restlessness
• trouble in sleeping

Less common

• Difficult or painful urination
• dizziness or light-headedness
• fast or pounding heartbeat
• headache
• increased sweating
• nausea or vomiting
• trembling
• unusual paleness
• weakness

Other side effects not listed may also happen 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.

In the U.S.

• 12 Hour Cold Maximum Strength
• Biofed
• Cenafed
• Chlor-Trimeton Nasal Decongestant
• Contac 12-Hour
• Dimetapp Decongestant
• Efidac 24 Pseudoephedrine
• ElixSure Congestion Children's
• Genaphed
• Pediacare Decongestant Infants
• Simply Stuffy
• Sudafed

Available Dosage Forms:

• Tablet
• Tablet, Extended Release
• Liquid
• Capsule, Liquid Filled
• Syrup
• Solution

Therapeutic Class: Decongestant

Pharmacologic Class: Sympathomimetic

For patients taking pseudoephedrine extended-release capsules:

• Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.
• Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets:

• Swallow the tablet whole.
• Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of side effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal or sinus congestion: For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets): Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours. Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours. Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours. Children and infants up to 4 years of age—Use is not recommended. For long-acting oral dosage form (extended-release capsules or extended-release tablets): Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours. Infants and children up to 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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