Contac 12-Hour (Oral)

Pseudoephedrine is used to relieve stuffiness in the nose or sinuses caused by the common cold, sinusitis, hay fever, and other allergies affecting the respiratory system. It is also used to help with ear congestion caused by inflammation or infection in the ear.

Some of these products are available only with a prescription from your doctor.

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 improve within 7 days, or if you have a high fever, contact your doctor. These signs may indicate that you have other medical issues.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction 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 newborn 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 of age. Using these medicines in very young children could lead to serious or possibly life-threatening side effects.

Geriatric

Many medicines have not been specifically studied in older people. Therefore, it may not be clear whether they work the same way they do in younger adults or if they cause different side effects or problems in older individuals. There is no specific information comparing the use of pseudoephedrine in elderly patients with other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In those instances, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is crucial that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of the other medicines you are taking.

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

Using this medicine with any of the following medicines is usually not recommended, but may be needed in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for 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 used around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been selected based on their potential significance and are not necessarily a complete list.

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, especially:

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

• Enlarged prostate or
• Glaucoma, or a tendency towards 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 necessary effects, a medicine may cause some unwanted effects. While not all of these side effects may happen, if they do, they may require medical attention.

Contact your doctor as soon as possible if you experience any of the following side effects:

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)
• Severe or continuing shortness of breath or troubled breathing
• Severe or continuing slow or fast heartbeat
• Unusual nervousness, restlessness, or excitement

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

More common

• Nervousness
• Restlessness
• Trouble 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 occur in some patients. If you notice any other effects, contact 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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