Children's Triacting Night Time

Name: Children's Triacting Night Time

What is Children's Triacting Night Time (diphenhydramine and phenylephrine)?

Diphenhydramine 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).

Diphenhydramine 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.

Diphenhydramine and phenylephrine 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.

Children's Triacting Night Time (diphenhydramine and phenylephrine) side effects

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

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

  • severe dizziness or nervousness;

  • severe drowsiness; or

  • little or no urination.

Side effects such as dry mouth, constipation, and confusion may be more likely in older adults.

Common side effects may include:

  • dizziness, drowsiness;

  • dry mouth, nose, or throat;

  • blurred vision; 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.

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.
  • Very bad dizziness or passing out.
  • A heartbeat that does not feel normal.
  • A fast heartbeat.
  • Feeling very tired or weak.
  • Any unexplained bruising or bleeding.
  • Change in balance.
  • Feeling confused.
  • Shakiness.
  • Change in eyesight.
  • Seizures.
  • Trouble passing urine.

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 diphenhydramine / phenylephrine: oral disintegrating strip, oral liquid, oral suspension extended release, oral tablet chewable extended release

Cardiovascular

Cardiovascular side effects have included hypotension, palpitations, tachycardia, and extrasystole.[Ref]

Hematologic

Hematologic side effects have included hemolytic anemia, agranulocytosis, and thrombocytopenia.[Ref]

Nervous system

Nervous system side effects have included sleepiness, sedation, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, headache, vertigo, tinnitus, acute labyrinthitis, neuritis, and convulsions.[Ref]

Ocular

Ocular side effects have included blurred vision and diplopia.[Ref]

Gastrointestinal

Gastrointestinal side effects have included epigastric distress, anorexia, nausea, vomiting, diarrhea, and constipation.[Ref]

Genitourinary

Genitourinary side effects have included urinary frequency, difficult urination, urinary retention, and early menses.[Ref]

Hypersensitivity

Hypersensitivity side effects have included urticaria, drug rash, anaphylactic shock, and photosensitivity.[Ref]

General

General side effects have included chills, excessive perspiration, and dryness of nose, throat and mouth.[Ref]

Some side effects of Children's Triacting Night Time may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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