Actifed Cold & Allergy

Name: Actifed Cold & Allergy

What is Actifed Cold & Allergy (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Chlorpheniramine and phenylephrine is a combination medicine used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for purposes not listed in this medication guide.

Actifed Cold & Allergy (chlorpheniramine and phenylephrine) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • chest pain, rapid pulse, fast or uneven heart rate;

  • confusion, hallucinations, severe nervousness;

  • tremor, seizure (convulsions);

  • little or no urinating;

  • easy bruising or bleeding, unusual weakness; or

  • dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, shortness of breath).

Common side effects may include:

  • dizziness, drowsiness, blurred vision;

  • dry nose or mouth;

  • nausea, stomach pain, constipation, loss of appetite;

  • problems with memory or concentration; or

  • feeling restless or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

Actifed Cold & Allergy Overview

Actifed Cold & Allergy is a brand name medication included in the following groups of medications: Substituted alkylamines, Adrenergic and dopaminergic agents, Sympathomimetics, Sympathomimetics excl. antiglaucoma preparations, Sympathomimetics used as decongestants, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain. For more information about Actifed Cold & Allergy see its generics Chlorphenamine, Phenylephrine

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Feeling nervous and excitable.
  • Not able to sleep.
  • Feeling sleepy.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to chlorpheniramine / phenylephrine: oral capsule extended release, oral drops, oral elixir, oral liquid, oral suspension, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release

General

General side effects including drowsiness, lassitude, giddiness, and increased irritability or excitement have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea and dryness of mouth have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including palpitations and flushing have been reported.[Ref]

Some side effects of Actifed Cold and Allergy may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Adult Dose for Allergic Rhinitis

Immediate-release tablets: 1 tablet (2 mg-5 mg) every 4 to 6 hours as needed or 1 tablet (4 mg-10 mg or 3 mg-10 mg) every 4 hours as needed. Not to exceed 6 doses in 24 hours.
Immediate-release liquid: 5 mL (4 mg-10 mg/5 mL) or (4 mg-12.5 mg/5 mL) 3 to 4 times a day as needed

Sustained-release tablets: 1 tablet (8 mg-20mg) or (9 mg-25 mg) every 12 hours as needed.
or 1 to 2 tablet(s) (4 mg-20mg) every 12 hours as needed

Sustained-release suspension:
chlorpheniramine-phenylephrine (3 mg-7.5 mg/ 5 mL) extended release suspension
15 mL orally every 12 hours as needed.

Usual Pediatric Dose for Allergic Rhinitis

chlorpheniramine-phenylephrine (1 mg-3.5 mg/mL) oral drops:
6 months to 11 months: 0.75 mL orally 4 times a day.
1 year to 2 years: 1 mL orally 4 times a day.

chlorpheniramine-phenylephrine (1 mg-2 mg/mL) oral drops:
2 years to 5 years: 1 mL orally every 4 to 6 hours as needed. Do not exceed 4 doses in 24 hours.
6 years to 12 years: 2 mL orally every 4 to 6 hours as needed. Do not exceed 4 doses in 24 hours.

chlorpheniramine-phenylephrine 1 mg-2.5 mg/ 5 mL oral drops:
6 years to 12 years: 10 mL orally every 4 hours. Do not exceed 6 doses in 24 hours.

chlorpheniramine-phenylephrine 2 mg-5 mg/ml oral drops:
2 years to 5 years: 0.5 mL every 4 hours. Do not exceed 6 doses in 24 hours.
6 years to 12 years: 1 mL every 4 hours. Do not exceed 6 doses in 24 hours.

chlorpheniramine-phenylephrine (3 mg-7.5 mg/ 5 mL) extended release suspension:
2 to 5 years: 1.25 to 2.5 ml orally every 12 hours as needed.
6 to 11 years: 2.5 to 5 ml orally every 12 hours as needed.
12 years or older: 15 ml orally every 12 hours as needed.

chlorpheniramine-phenylephrine (4 mg-7.5 mg/ 20 mL) extended release suspension:
2 to 5 years: 2.5 ml orally every 12 hours as needed.
6 to 11 years: 5 ml orally every 12 hours as needed.
12 years or older: 10 ml orally every 12 hours as needed.

chlorpheniramine-phenylephrine (4 mg-10 mg or 3 mg-10 mg) oral tablet:
6 to 11 years: one half tablet orally every 4 hours as needed.
12 years or older: one tablet orally every 4 hours as needed.
Not to exceed 6 doses in 24 hours.

chlorpheniramine-phenylephrine (4 mg-12.5 mg/ 5 mL) oral syrup;
2 to 5 years: 1.25 ml orally every 4 hours to 6 hours, not to exceed 7.5 mL in 24 hours.
6 to 11 years: 2.5 ml orally every 4 hours to 6 hours, not to exceed 15 mL in 24 hours.
12 years or older: 5 ml orally every 4 hours to 6 hours, not to exceed 30 mL in 24 hours.

chlorpheniramine-phenylephrine (4.5 mg-5 mg/ 5 mL) extended release suspension:
2 to 5 years: 2.5 ml to 5 mL orally every 12 hours.
6 to 11 years: 2.5 ml to 10 mL orally every 12 hours.

chlorpheniramine-phenylephrine (4 mg-20 mg) extended release capsule:
6 to 12 years: one capsule orally every 12 hours, not to exceed 2 capsules in 24 hours.
12 years or older: two capsules orally every 12 hours, not to exceed 4 capsules in 24 hours.

chlorpheniramine-phenylephrine (8 mg-20 mg) extended release tablet:
6 to 12 years: one-half tablet orally every 12 hours.
12 years or older: one tablet orally every 12 hours.

Usual Pediatric Dose for Cold Symptoms

chlorpheniramine-phenylephrine (1 mg-3.5 mg/mL) oral drops:
6 months to 11 months: 0.75 mL orally 4 times a day.
1 year to 2 years: 1 mL orally 4 times a day.

chlorpheniramine-phenylephrine (1 mg-2 mg/mL) oral drops:
2 years to 5 years: 1 mL orally every 4 to 6 hours as needed. Do not exceed 4 doses in 24 hours.
6 years to 12 years: 2 mL orally every 4 to 6 hours as needed. Do not exceed 4 doses in 24 hours.

chlorpheniramine-phenylephrine 1 mg-2.5 mg/ 5 mL oral drops:
6 years to 12 years: 10 mL orally every 4 hours. Do not exceed 6 doses in 24 hours.

chlorpheniramine-phenylephrine 2 mg-5 mg/ml oral drops:
2 years to 5 years: 0.5 mL every 4 hours. Do not exceed 6 doses in 24 hours.
6 years to 12 years: 1 mL every 4 hours. Do not exceed 6 doses in 24 hours.

chlorpheniramine-phenylephrine (3 mg-7.5 mg/ 5 mL) extended release suspension:
2 to 5 years: 1.25 to 2.5 ml orally every 12 hours as needed.
6 to 11 years: 2.5 to 5 ml orally every 12 hours as needed.
12 years or older: 15 ml orally every 12 hours as needed.

chlorpheniramine-phenylephrine (4 mg-7.5 mg/ 20 mL) extended release suspension:
2 to 5 years: 2.5 ml orally every 12 hours as needed.
6 to 11 years: 5 ml orally every 12 hours as needed.
12 years or older: 10 ml orally every 12 hours as needed.

chlorpheniramine-phenylephrine (4 mg-10 mg or 3 mg-10 mg) oral tablet:
6 to 11 years: one half tablet orally every 4 hours as needed.
12 years or older: one tablet orally every 4 hours as needed.
Not to exceed 6 doses in 24 hours.

chlorpheniramine-phenylephrine (4 mg-12.5 mg/ 5 mL) oral syrup;
2 to 5 years: 1.25 ml orally every 4 hours to 6 hours, not to exceed 7.5 mL in 24 hours.
6 to 11 years: 2.5 ml orally every 4 hours to 6 hours, not to exceed 15 mL in 24 hours.
12 years or older: 5 ml orally every 4 hours to 6 hours, not to exceed 30 mL in 24 hours.

chlorpheniramine-phenylephrine (4.5 mg-5 mg/ 5 mL) extended release suspension:
2 to 5 years: 2.5 ml to 5 mL orally every 12 hours.
6 to 11 years: 2.5 ml to 10 mL orally every 12 hours.

chlorpheniramine-phenylephrine (4 mg-20 mg) extended release capsule:
6 to 12 years: one capsule orally every 12 hours, not to exceed 2 capsules in 24 hours.
12 years or older: two capsules orally every 12 hours, not to exceed 4 capsules in 24 hours.

chlorpheniramine-phenylephrine (8 mg-20 mg) extended release tablet:
6 to 12 years: one-half tablet orally every 12 hours.
12 years or older: one tablet orally every 12 hours.

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