Rx Item-Karbinal ER 4Mg/5Ml Suspension 16 Oz By Zypera Pharma

KARBINAL ER- carbinoxamine maleate suspension, extended release
FSC Laboratories, Inc

1 INDICATIONS AND USAGE

Karbinal ER Extended-release Oral Suspension is an H1 receptor antagonist indicated for the symptomatic treatment of:

Seasonal and perennial allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and angioedema
Dermatographism
As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled
Amelioration of the severity of allergic reactions to blood or plasma
2 DOSAGE AND ADMINISTRATION



The dosage of Karbinal ER should be individualized based on the severity of the condition and the response of the patient. Start with lower doses and increase as needed and tolerated.

Administer Karbinal ER by the oral route only. Measure Karbinal ER with an accurate milliliter measuring device. A household teaspoon is not an accurate measuring device and could lead to overdosage. A pharmacist can provide an appropriate measuring device and can provide instructions for measuring the correct dose. [see Warnings and Precautions (5.5) ]

Adults and Adolescents 12 years of age and older:

7.5 mL to 20 mL (6 to 16 mg) every 12 hours

Children 2 to 11 years of age (approximately 0.2 to 0.4 mg/kg/day):

2 to 3 years: 3.75 mL to 5 mL (3 to 4 mg) every 12 hours

4 to 5 years: 3.75 mL to 10 mL (3 to 8 mg) every 12 hours

6 to 11 years: 7.5 mL to 15 mL (6 to 12 mg) every 12 hours

3 DOSAGE FORMS AND STRENGTHS

Extended-release oral suspension containing 4 mg carbinoxamine maleate per 5 mL

RX ITEM-Karbinal ER 4Mg/5Ml Suspension 1
NDC 13551-0101-05 UPC/GTIN No.3-13551-10105-9 Mfg.Part No.10105

Karbinal ER 4Mg/5Ml Suspension 16 Oz By
BRAND: KARBINAL-ER NDC: 23594-0101-05,23594010105 UPC: 323-594-10105-3,323594101053 FSC Labs Inc.

CARBINOXAMINE MALEATE ORA
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