Pseudoephedrine

Pseudoephedrine is an over-the-counter medication. It is used to treat stuffy nose. Pseudoephedrine belongs to a group of drugs called nasal decongestants. It works by shrink the size of blood vessels in your nose that cause congestion when symptoms occur.

This medication comes in tablets and extended release tablet form. Regular tablets are taken four to six times per day as needed. The extended release tablets are taken up to twice a day with a glass of water.

Do not chew, divide, or break pseudoephedrine extended release tablets. Swallow pseudoephedrine extended release tablets whole.

Pseudoephedrine also comes as a solution and chew tablets for dosing in children.

Pseudoephedrine can also cause fast pounding heart beat (that you can feel in your chest), dizziness, and ringing in your ears. Do not drive or operate heavy machinery until you know how pseudoephedrine affects you.

Serious side effects have been reported with pseudoephedrine. See the “Pseudoephedrine Precautions” section.

Common side effects of pseudoephedrine include the following:

• loss of appetite
• warm tingling skin
• restlessness or excitability
• difficulty sleeping

This is not a complete list of pseudoephedrine side effects. Ask your doctor or pharmacist for more information

.Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with pseudoephedrine including the following:

• Fast pounding heartbeat. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • heartbeat you can feel in your chest
  • thumping feeling in your chest

• Severe dizziness or anxiety. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • lightheaded
  • loss of balance
  • nausea
  • excited or panic feeling

• High blood pressure. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • severe headache
  • blurred vision
  • ringing in you ears
  • chest pain

Pseudoephedrine can cause drowsiness or feelings that may impair your ability to drive . Do not drive or operate heavy machinery until you know how pseudoephedrine affects you.

Do not take pseudoephedrine if you

• are allergic to pseudoephedrine or any of its ingredients
• do not take pseudoephedrine if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking one of these medications within the past 2 weeks.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pseudoephedrine, there are no specific foods that you must exclude from your diet when receiving this medication. However, foods and drinks that contain large amounts of caffeine can make the side effects of pseudoephedrine worse.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories ­ A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

There are no well­ controlled studies that have been done in pregnant women. Pseudoephedrine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Do not use pseudoephedrine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Always ask a doctor before giving a cough or cold medicine to a child.

You should not use this medicine if you are allergic to pseudoephedrine.

Do not use pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Ask a doctor or pharmacist if it is safe for you to use pseudoephedrine if you have other medical conditions, especially:

• heart disease or high blood pressure;

• enlarged prostate and urination problems;

• diabetes; or

• a thyroid disorder.

Artificially sweetened liquid medicine may contain phenylalanine. Check the medication label if you have phenylketonuria (PKU).

It is not known whether pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Storage

Oral

Conventional tablets: 15–25°C in a dry place.108

Extended-release tablets: 15–25°C in a dry place.109 Protect from light.109

15–25°C in a dry place.108 109 Avoid freezing.a

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, Oral, as hydrochloride:

ElixSure Congestion: 15 mg/5 mL (120 mL [DSC]) [alcohol free; contains brilliant blue fcf (fd&c blue #1), carbomer 934p, propylene glycol, propylparaben]

Liquid, Oral, as hydrochloride:

Childrens Silfedrine: 15 mg/5 mL (118 mL, 237 mL) [grape flavor]

Nasal Decongestant: 30 mg/5 mL (118 mL) [contains fd&c red #40, methylparaben, saccharin sodium, sodium benzoate; raspberry flavor]

Sudafed Childrens: 15 mg/5 mL (118 mL) [alcohol free, sugar free; contains brilliant blue fcf (fd&c blue #1), edetate disodium, fd&c red #40, menthol, polyethylene glycol, saccharin sodium, sodium benzoate; grape flavor]

Syrup, Oral, as hydrochloride:

Nasal Decongestant: 30 mg/5 mL (473 mL) [contains fd&c red #40, methylparaben, saccharin sodium, sodium benzoate; raspberry flavor]

Tablet, Oral, as hydrochloride:

Genaphed: 30 mg

Nasal Decongestant: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Nasal Decongestant: 30 mg [contains fd&c red #40 aluminum lake, polysorbate 80]

Psudatabs: 30 mg [DSC] [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Shopko Nasal Decongestant Max: 30 mg [contains fd&c red #40 aluminum lake]

Simply Stuffy: 30 mg

Sudafed: 30 mg

Sudafed: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Sudafed Congestion: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Sudanyl: 30 mg [DSC]

SudoGest: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

SudoGest: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

SudoGest: 60 mg [scored]

Suphedrine: 30 mg [DSC]

Generic: 30 mg, 60 mg

Tablet Abuse-Deterrent, Oral, as hydrochloride:

Nexafed: 30 mg

Zephrex-D: 30 mg

Tablet Extended Release 12 Hour, Oral, as hydrochloride:

Decongestant 12Hour Max St: 120 mg [contains polysorbate 80]

Shopko Nasal Decongestant: 120 mg

Sudafed 12 Hour: 120 mg

Sudafed 12 Hour: 120 mg [DSC] [contains fd&c blue #1 aluminum lake]

SudoGest 12 Hour: 120 mg

Generic: 120 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride:

Sudafed 24 Hour: 240 mg

• Alpha/Beta Agonist
• Decongestant