V-HIST Suspension

V-HIST Suspension: Administer the recommended dose up to four times daily

CHILDREN

Over 12 years of age - 5 to 10 mL (1 to 2 teaspoonfuls);
6 to 12 years of age - 5 mL (1 teaspoonful);
2 to 6 years of age - 2.5 mL (1/2 teaspoonful);
Under 2 years of age - Consult a physician.

Each 5 mL of V-HIST Suspension contains:
6 mg Brompheniramine Maleate and 10 mg Phenylephrine HCl.

Note: The Hydrochloride salt of Phenylephrine and the Maleate salt of Brompheniramine are provided in a suspension by means of a patented manufacturing process.

Applies to brompheniramine / phenylephrine: oral elixir, oral liquid, oral suspension, oral syrup, oral tablet, oral tablet chewable

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 nervous and excitable.
• 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.

Applies to brompheniramine / phenylephrine: oral capsule extended release, oral elixir, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable, oral tablet chewable extended release, oral tablet extended release

Gastrointestinal

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

Cardiovascular

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

Genitourinary

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

Respiratory

Respiratory side effects have included thickening of bronchial secretions, tightness of chest, wheezing, and nasal stuffiness.[Ref]

Hematologic

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

Nervous system

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

Ocular

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

Dermatologic

Dermatologic side effects have included photosensitivity, excessive perspiration, and flushing.[Ref]

General

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

Hypersensitivity

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

Some side effects of V-HIST may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.