Phenylephrine and promethazine

Name: Phenylephrine and promethazine

What is phenylephrine and promethazine?

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

Promethazine 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 and promethazine is a combination medicine used to treat sneezing, runny nose, watery eyes, hives, skin rash, itching, and other cold or allergy symptoms.

Phenylephrine and promethazine may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Phenylephrine and promethazine dosing information

Usual Adult Dose for Allergic Rhinitis:

5 mL orally every 4 to 6 hours
Maximum dose: 30 mL in 24 hours (promethazine 37.5 mg; phenylephrine 30 mg)

Comments:
-Each 5 mL contains promethazine 6.25 mg and phenylephrine 5 mg.

Use: For the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Usual Adult Dose for Cold Symptoms:

5 mL orally every 4 to 6 hours
Maximum dose: 30 mL in 24 hours (promethazine 37.5 mg; phenylephrine 30 mg)

Comments:
-Each 5 mL contains promethazine 6.25 mg and phenylephrine 5 mg.

Use: For the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Usual Pediatric Dose for Allergic Rhinitis:

Less than 2 years: Contraindicated

2 years to less than 6 years: 1.25 to 2.5 mL orally every 4 to 6 hours
Maximum dose: 15 mL in 24 hours (promethazine 18.75 mg; phenylephrine 15 mg)

6 years to less than 12 years: 2.5 to 5 mL orally every 4 to 6 hours
Maximum dose: 30 mL in 24 hours (promethazine 37.5 mg; phenylephrine 30 mg)

12 years to 18 years: 5 mL orally every 4 to 6 hours
Maximum dose: 30 mL in 24 hours (promethazine 37.5 mg; phenylephrine 30 mg)

Comments:
-Each 5 mL contains promethazine 6.25 mg and phenylephrine 5 mg.
-Extra caution is advised with use of promethazine in children as respiratory depression is strongly associated with use; however, its occurrence is not directly related to individualized weight base dosing.

Use: For the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

Usual Pediatric Dose for Cold Symptoms:

Less than 2 years: Contraindicated

2 years to less than 6 years: 1.25 to 2.5 mL orally every 4 to 6 hours
Maximum dose: 15 mL in 24 hours (promethazine 18.75 mg; phenylephrine 15 mg)

6 years to less than 12 years: 2.5 to 5 mL orally every 4 to 6 hours
Maximum dose: 30 mL in 24 hours (promethazine 37.5 mg; phenylephrine 30 mg)

12 years to 18 years: 5 mL orally every 4 to 6 hours
Maximum dose: 30 mL in 24 hours (promethazine 37.5 mg; phenylephrine 30 mg)

Comments:
-Each 5 mL contains promethazine 6.25 mg and phenylephrine 5 mg.
-Extra caution is advised with use of promethazine in children as respiratory depression is strongly associated with use; however, its occurrence is not directly related to individualized weight base dosing.

Use: For the temporary relief of upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.

For the Consumer

Applies to phenylephrine / promethazine: oral solution, oral syrup

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
  • Fast or slow heartbeat.
  • Trouble passing urine.
  • Feeling very tired or weak.
  • Hallucinations (seeing or hearing things that are not there).
  • Mood changes.
  • Ringing in ears.
  • Seizures.
  • Any unexplained bruising or bleeding.
  • Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
  • Change in eyesight.
  • Yellow skin or eyes.
  • A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.
  • This drug may cause very bad and sometimes deadly breathing problems. Call your doctor right away if you have slow, shallow, or trouble breathing.
  • Low white blood cell counts have rarely happened with this drug. This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

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:

  • Feeling sleepy.
  • Dizziness.
  • Feeling tired or weak.
  • Feeling nervous and excitable.
  • Dry mouth.
  • Upset stomach or throwing up.
  • Not able to sleep.

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.

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