Triaminic Cough & Runny Nose

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Since this medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these 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:

• fast, slow, or uneven heart rate;

• severe dizziness or anxiety, feeling like you might pass out;

• mood changes, severe headache;

• fever;

• tremor, seizure (convulsions);

• little or no urinating; or

• easy bruising or bleeding, unusual weakness.

Common side effects may include:

• mild dizziness, drowsiness;

• dry mouth, nose, or throat;

• constipation, diarrhea;

• blurred vision; or

• feeling nervous, restless, or irritable.

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.

• It is used to relieve coughing.
• It is used to ease allergy signs.

• Tell all of your health care providers that you take Triaminic Cough/Runny Nose. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Triaminic Cough/Runny Nose affects you.
• Do not use with other products that have diphenhydramine.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you are 60 or older, use Triaminic Cough/Runny Nose with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• Different brands of Triaminic Cough/Runny Nose may be for use in different ages of children. Talk with the doctor before giving this medicine to a child.
• Do not use to make a child sleepy. Talk with the doctor.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

More frequent side effects include: sedation and thickening of bronchial secretions. See below for a comprehensive list of adverse effects.

Applies to diphenhydramine: compounding powder, injectable solution, oral capsule, oral disintegrating strip, oral liquid, oral tablet, oral tablet chewable, oral tablet disintegrating

General

The most commonly reported side effects included somnolence, dizziness, and incoordination.[Ref]

Nervous system

Common (1% to 10%): Sedation/somnolence/sleepiness, drowsiness, unsteadiness, dizziness, headache, attention disturbance
Rare (0.01% to 0.1%): Extrapyramidal effects, tremor, convulsions
Frequency not reported: Paresthesia, dyskinesia/muscle dyskinesia, vertigo, neuritis, incoordination, psychomotor impairment, activation of epileptogenic foci[Ref]

Drowsiness usually diminishes after a few days.[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth
Frequency not reported: Gastrointestinal disturbance, nausea, vomiting, constipation, diarrhea, dyspepsia, epigastric distress[Ref]

Other

Common (1% to 10%): Fatigue
Frequency not reported: Lassitude, tinnitus, acute labyrinthitis, asthenia, chills, impaired performance (including impaired driving, work, and/or information processing)[Ref]

Psychiatric

Rare (0.01% to 0.1%): Confusion, depression, sleep disturbances
Frequency not reported: Paradoxical excitation/excitation, agitation, increased energy, restlessness, nervousness, euphoria, anxiety, hallucinations, insomnia, irritability[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Palpitations, hypotension, arrhythmia
Frequency not reported: Tachycardia, chest tightness, extrasystoles[Ref]

Hematologic

Rare (0.01% to 0.1%): Blood disorders
Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Frequency not reported: Angioedema, anaphylactic shock[Ref]

Hepatic

Rare (0.01% to 0.1%): Liver dysfunction[Ref]

Dermatologic

Frequency not reported: Rash, urticaria, skin rashes, erythema, photosensitivity, pruritus, drug rash, excessive perspiration[Ref]

Respiratory

Frequency not reported: Dyspnea, thickening of bronchial secretions, throat tightening, wheezing, nasal stuffiness, dry nose or throat[Ref]

Genitourinary

Frequency not reported: Urinary hesitancy/difficulty/retention, dysuria, early menses[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes, diplopia[Ref]

Metabolic

Frequency not reported: Increased appetite, anorexia[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching/weakness[Ref]

Some side effects of Triaminic Thin Strips Cough & Runny Nose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.