Alenaze-D

Name: Alenaze-D

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.

What are some other side effects of Alenaze-D?

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.

For the Consumer

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

For Healthcare Professionals

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

Usual Adult Dose for Allergic Rhinitis

Brompheniramine-phenylephrine 12 mg-15 mg oral capsule, extended release:
1 capsule orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-10 mg/5 mL oral suspension:
5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 12 mg-20 mg/5 mL oral suspension:
5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 1 mg-2.5 mg/5 mL oral liquid:
20 mL orally every 4 to 6 hours not to exceed 120 mL daily.

Brompheniramine-phenylephrine 2 mg-7.5 mg/5 mL oral liquid:
10 mL orally every 6 hours not to exceed 40 mL daily.

Brompheniramine-phenylephrine 6 mg-7.5 mg oral capsule, extended release:
1 to 2 capsules orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-5 mg/5 mL oral suspension:
5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 6 mg-30 mg oral tablet, extended release:
1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-19 mg oral tablet, extended release:
1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-10 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours, not to exceed 40 mL in a 24 hour period.

Brompheniramine-phenylephrine 12 mg-10 mg/5 mL oral suspension, extended release:
5 to 10 mL orally every 12 hours, not to exceed 20 mL in a 24 hour period.

Usual Adult Dose for Rhinitis

Brompheniramine-phenylephrine 12 mg-15 mg oral capsule, extended release:
1 capsule orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-10 mg/5 mL oral suspension:
5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 12 mg-20 mg/5 mL oral suspension:
5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 1 mg-2.5 mg/5 mL oral liquid:
20 mL orally every 4 to 6 hours not to exceed 120 mL daily.

Brompheniramine-phenylephrine 2 mg-7.5 mg/5 mL oral liquid:
10 mL orally every 6 hours not to exceed 40 mL daily.

Brompheniramine-phenylephrine 6 mg-7.5 mg oral capsule, extended release:
1 to 2 capsules orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-5 mg/5 mL oral suspension:
5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 6 mg-30 mg oral tablet, extended release:
1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-19 mg oral tablet, extended release:
1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-10 mg/5 mL oral liquid:
5 to 10 mL orally every 4 to 6 hours, not to exceed 40 mL in a 24 hour period.

Brompheniramine-phenylephrine 12 mg-10 mg/5 mL oral suspension, extended release:
5 to 10 mL orally every 12 hours, not to exceed 20 mL in a 24 hour period.

Usual Pediatric Dose for Allergic Rhinitis

Brompheniramine-phenylephrine 1 mg-2.5 mg/5 mL oral liquid:
6 to 11 yrs: 10 mL orally every 4 to 6 hours not to exceed 60 mL daily.
12 yrs or older: 20 mL orally every 4 to 6 hours not to exceed 120 mL daily.

Brompheniramine-phenylephrine 12 mg-15 mg oral capsule, extended release:
12 yrs or older:1 capsule orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-10 mg/5 mL oral suspension:
2 to 5 yrs: 2.5 mL orally every 12 hours not to exceed 5 mL daily.
6 to 11 yrs: 5 mL orally every 12 hours not to exceed 10 mL daily
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 12 mg-20 mg/5 mL oral suspension:
2 to 5 yrs: 2.5 mL orally every 12 hours not to exceed 5 mL daily.
6 to 11 yrs: 5 mL orally every 12 hours not to exceed 10 mL daily.
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 2 mg-7.5 mg/5 mL oral liquid:
2 to 5 yrs: 2.5 mL orally every 6 hours not to exceed 10 mL daily.
6 to 11 yrs: 5 mL orally every 6 hours not to exceed 20 mL daily.
12 yrs or older: 10 mL orally every 6 hours not to exceed 40 mL daily.

Brompheniramine-phenylephrine 6 mg-7.5 mg oral capsule, extended release:
6 to 11 yrs: 1 capsule orally every 12 hours.
12 yrs or older: 1 to 2 capsules orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-7.5 mg/5 mL oral liquid:
2 to 5 yrs: 1.25 mL orally every 6 hours, not to exceed 7.5 mL in a 24 hour period.
6 to 11 yrs: 2.5 mL orally every 6 hours, not to exceed 15 mL in a 24 hour period.
12 yrs or older: 5 mL orally every 6 hours, not to exceed 30 mL in a 24 hour period.

Brompheniramine-phenylephrine 4 mg-5 mg/5 mL oral suspension:
2 to 5 yrs: 2.5 mL orally every 12 hours, not to exceed 5 mL in a 24 hour period.
6 to 11 yrs: 5 mL orally every 12 hours, not to exceed 10 mL in a 24 hour period.
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

brompheniramine-pseudoephedrine 1 mg-7.5 mg/mL oral liquid:
1 to 2 months: 0.25 mL orally 4 times a day
3 to 5 months: 0.5 mL orally 4 times a day
6 to 11 months: 0.75 mL orally 4 times a day
12 to 24 months: 1 mL orally 4 times a day
Not to exceed 4 doses in 24 hours.

Brompheniramine-phenylephrine 6 mg-30 mg oral tablet, extended release:
12 yrs or older: 1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 1 mg-2.5 mg oral tablet, chewable:
6 to 11 yrs: 2 tablets orally every 4 hours, not to exceed 6 doses in 24 hours.

Brompheniramine-phenylephrine 6 mg-19 mg oral tablet, extended release:
12 yrs or older: 1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-15 mg oral tablet, chewable, extended release:
6 to 11 yrs: 1/2 tablet orally every 12 hours.
12 yrs or older: 1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-10 mg/5 mL oral liquid:
2 to 5 yrs: 2.5 mL orally every 4 to 6 hours, not to exceed 10 mL in a 24 hour period.
6 to 11 yrs: 5 mL orally every 4 to 6 hours, not to exceed 20 mL in a 24 hour period.
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 40 mL in a 24 hour period.

Brompheniramine-phenylephrine 12 mg-10 mg/5 mL oral suspension, extended release:
6 to 11 yrs: 5 mL orally every 12 hours, not to exceed 10 mL in a 24 hour period.
12 yrs or older: 5 to 10 mL orally every 12 hours, not to exceed 20 mL in a 24 hour period.

Usual Pediatric Dose for Rhinitis

Brompheniramine-phenylephrine 1 mg-2.5 mg/5 mL oral liquid:
6 to 11 yrs: 10 mL orally every 4 to 6 hours not to exceed 60 mL daily.
12 yrs or older: 20 mL orally every 4 to 6 hours not to exceed 120 mL daily.

Brompheniramine-phenylephrine 12 mg-15 mg oral capsule, extended release:
12 yrs or older:1 capsule orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-10 mg/5 mL oral suspension:
2 to 5 yrs: 2.5 mL orally every 12 hours not to exceed 5 mL daily.
6 to 11 yrs: 5 mL orally every 12 hours not to exceed 10 mL daily
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 12 mg-20 mg/5 mL oral suspension:
2 to 5 yrs: 2.5 mL orally every 12 hours not to exceed 5 mL daily.
6 to 11 yrs: 5 mL orally every 12 hours not to exceed 10 mL daily.
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

Brompheniramine-phenylephrine 2 mg-7.5 mg/5 mL oral liquid:
2 to 5 yrs: 2.5 mL orally every 6 hours not to exceed 10 mL daily.
6 to 11 yrs: 5 mL orally every 6 hours not to exceed 20 mL daily.
12 yrs or older: 10 mL orally every 6 hours not to exceed 40 mL daily.

Brompheniramine-phenylephrine 6 mg-7.5 mg oral capsule, extended release:
6 to 11 yrs: 1 capsule orally every 12 hours.
12 yrs or older: 1 to 2 capsules orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-7.5 mg/5 mL oral liquid:
2 to 5 yrs: 1.25 mL orally every 6 hours, not to exceed 7.5 mL in a 24 hour period.
6 to 11 yrs: 2.5 mL orally every 6 hours, not to exceed 15 mL in a 24 hour period.
12 yrs or older: 5 mL orally every 6 hours, not to exceed 30 mL in a 24 hour period.

Brompheniramine-phenylephrine 4 mg-5 mg/5 mL oral suspension:
2 to 5 yrs: 2.5 mL orally every 12 hours, not to exceed 5 mL in a 24 hour period.
6 to 11 yrs: 5 mL orally every 12 hours, not to exceed 10 mL in a 24 hour period.
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 20 mL daily.

brompheniramine-pseudoephedrine 1 mg-7.5 mg/mL oral liquid:
1 to 2 months: 0.25 mL orally 4 times a day
3 to 5 months: 0.5 mL orally 4 times a day
6 to 11 months: 0.75 mL orally 4 times a day
12 to 24 months: 1 mL orally 4 times a day
Not to exceed 4 doses in 24 hours.

Brompheniramine-phenylephrine 6 mg-30 mg oral tablet, extended release:
12 yrs or older: 1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 1 mg-2.5 mg oral tablet, chewable:
6 to 11 yrs: 2 tablets orally every 4 hours, not to exceed 6 doses in 24 hours.

Brompheniramine-phenylephrine 6 mg-19 mg oral tablet, extended release:
12 yrs or older: 1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 6 mg-15 mg oral tablet, chewable, extended release:
6 to 11 yrs: 1/2 tablet orally every 12 hours.
12 yrs or older: 1 tablet orally every 12 hours.

Brompheniramine-phenylephrine 4 mg-10 mg/5 mL oral liquid:
2 to 5 yrs: 2.5 mL orally every 4 to 6 hours, not to exceed 10 mL in a 24 hour period.
6 to 11 yrs: 5 mL orally every 4 to 6 hours, not to exceed 20 mL in a 24 hour period.
12 yrs or older: 5 to 10 mL orally every 12 hours not to exceed 40 mL in a 24 hour period.

Brompheniramine-phenylephrine 12 mg-10 mg/5 mL oral suspension, extended release:
6 to 11 yrs: 5 mL orally every 12 hours, not to exceed 10 mL in a 24 hour period.
12 yrs or older: 5 to 10 mL orally every 12 hours, not to exceed 20 mL in a 24 hour period.

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