Children's Triacting Night Time Side Effects

Generic name: diphenhydramine / phenylephrine

Note: This document contains side effect information about diphenhydramine / phenylephrine. Some of the dosage forms listed on this page may not apply to the brand name Children's Triacting Night Time.

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.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking diphenhydramine / phenylephrine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heartbeat;

• confusion, hallucinations, unusual thoughts or behavior;

• urinating less than usual or not at all;

• severe dizziness, anxiety, restless feeling, or nervousness;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of diphenhydramine / phenylephrine may include:

• blurred vision;

• dry mouth;

• nausea, stomach pain, constipation;

• dizziness, drowsiness;

• problems with memory or concentration;

• ringing in your ears;

• mild loss of appetite;

• warmth, tingling, or redness under your skin;

• feeling excited or restless;

• sleep problems (insomnia); or

• skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

Hematologic

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

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.

Ocular

Ocular side effects have included blurred vision and diplopia.

Gastrointestinal

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

Genitourinary

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

Hypersensitivity

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

General

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

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