Pediacare Decongestant Infants (Oral)

Pseudoephedrine helps to relieve stuffiness in your nose or sinuses due to the common cold, sinusitis, hay fever, and other respiratory allergies. It also helps to relieve ear congestion that can happen from ear inflammation or infection.

Some of these products can only be obtained 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 old. Using these medicines in very young children could lead to serious or possibly life-threatening side effects.

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

In deciding to use a medicine, you need to consider the risks of taking it against the benefits it can provide. This is a choice you will make with your doctor. For this medicine, keep the following in mind:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, compared to 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 studied specifically in older people. Therefore, it may not be known if they work the same way in older adults as they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of pseudoephedrine in elderly patients with use in other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during 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 is possible. In these situations, your doctor may want to adjust the dose, or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been highlighted based on their potential significance and are not necessarily all-inclusive.

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 your other medicines.

• 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of using one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been highlighted based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

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

• Enlarged prostate or
• Glaucoma, or a family history of glaucoma or
• Heart disease or blood vessel disease or
• High blood pressure—Pseudoephedrine may worsen the condition

• Overactive thyroid—Using pseudoephedrine may worsen the condition

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

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

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 difficulty breathing

Symptoms of overdose

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

Some side effects may occur that usually do not need medical attention. These side effects may disappear during treatment as your body adjusts to the medicine. Your healthcare professional may also provide ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects persist, are bothersome, or if you have 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 happen in some patients. If you notice any other effects, consult 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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