Usual Adult Dose for Allergic Rhinitis

2.5 mg orally every 6 hours as needed

• Maximum dose: 10 mg/day

Comment: Patients should not take more than 4 doses/day unless directed by their healthcare provider.

Use: For the temporary relief of runny nose, sneezing, nose/throat itching, and/or itchy, watery eyes due to allergic rhinitis (hay fever) or other upper respiratory allergies

Usual Adult Dose for Allergic Conjunctivitis

2.5 mg orally every 6 hours as needed

• Maximum dose: 10 mg/day

Comment: Patients should not take more than 4 doses/day unless directed by their healthcare provider.

Use: For the temporary relief of runny nose, sneezing, nose/throat itching, and/or itchy, watery eyes due to allergic rhinitis (hay fever) or other upper respiratory allergies

Usual Pediatric Dose for Allergic Rhinitis

4 months to less than 2 years: 0.310 to 0.313 mg orally every 4 to 6 hours as needed

• Maximum dose: 1.25 mg/day

2 years to less than 4 years: 0.625 to 0.628 mg orally every 4 to 6 hours as needed

• Maximum dose: 2.5 mg/day

4 years to less than 6 years: 0.938 to 0.939 mg orally every 4 to 6 hours as needed

• Maximum dose: 3.75 mg/day

6 years to less than 12 years: 1.25 mg orally every 6 hours as needed

• Maximum dose: 5 mg/day

12 years and older: 2.5 mg orally every 6 hours as needed

• Maximum dose: 10 mg/day

Comments:

• Patients should not take more than 4 doses/day unless directed by their healthcare provider.
• Dosing in patients 4 months to 6 years should be performed under the guidance of a healthcare professional.

Use: For the temporary relief of runny nose, sneezing, nose/throat itching, and/or itchy, watery eyes due to allergic rhinitis (hay fever) or other upper respiratory allergies

Usual Pediatric Dose for Allergic Conjunctivitis

4 months to less than 2 years: 0.310 to 0.313 mg orally every 4 to 6 hours as needed

• Maximum dose: 1.25 mg/day

2 years to less than 4 years: 0.625 to 0.628 mg orally every 4 to 6 hours as needed

• Maximum dose: 2.5 mg/day

4 years to less than 6 years: 0.938 to 0.939 mg orally every 4 to 6 hours as needed

• Maximum dose: 3.75 mg/day

6 years to less than 12 years: 1.25 mg orally every 6 hours as needed

• Maximum dose: 5 mg/day

12 years and older: 2.5 mg orally every 6 hours as needed

• Maximum dose: 10 mg/day

Comments:

• Patients should not take more than 4 doses/day unless directed by their healthcare provider.
• Dosing in patients 4 months to 6 years should be performed under the guidance of a healthcare professional.

Use: For the temporary relief of runny nose, sneezing, nose/throat itching, and/or itchy, watery eyes due to allergic rhinitis (hay fever) or other upper respiratory allergies

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Patients taking sedatives or tranquilizers without first consulting their healthcare provider
• With any other product containing this drug

Safety and efficacy have not been established in patients younger than 4 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Oral solutions and syrups should be used with the enclosed oral syringe/dropper.
• Oral syringes/droppers should not be used to dose other drug products.

Storage requirements:

• Syrup: Protect from light.

General:

• This drug should not be used if the tamper evident seal is broken/missing.

Patient advice:

• Patients should be told that the recommended dose should not be exceeded.
• Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery if these side effects occur.
• Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.