Hawthorn Pharmaceuticals, Inc.

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Hawthorn Pharmaceuticals, Inc. Drugs

Reprexain

Reprexain

Carefully consider the potential benefits and risks of REPREXAIN™ (hydrocodone bitartrate and ibuprofen tablets) and other treatment options before deciding to use REPREXAIN™. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with REPREXAIN™, the dose and frequency should be adjusted to suit an individual patient’s needs. For the short-term (generally less than 10 days) management of acute pain, the recommended dose of REPREXAIN™ is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. It should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The lowest effective dose or the longest dosing interval should be sought for each patient (see WARNINGS), especially in the elderly. After observing the initial response to therapy with REPREXAIN™, the dose and frequency of dosing should be adjusted to suit the individual patient’s need, without exceeding the total daily dose recommended.
Reprexain

Reprexain

Carefully consider the potential benefits and risks of REPREXAIN™ and other treatment options before deciding to use REPREXAIN™. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with REPREXAIN™, the dose and frequency should be adjusted to suit an individual patient’s needs. For the short-term (generally less than 10 days) management of acute pain, the recommended dose of REPREXAIN™ is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. It should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related. The lowest effective dose or the longest dosing interval should be sought for each patient (see WARNINGS), especially in the elderly. After observing the initial response to therapy with REPREXAIN™, the dose and frequency of dosing should be adjusted to suit the individual patient’s need, without exceeding the total daily dose recommended.
Nasotuss

Nasotuss

Do not exceed recommended dosage. Adults and children12 years of age and older: 1 teaspoonful (5 mL) every6 to 8 hours, not to exceed3 teaspoonfuls in a24 hour period. Children 6 to under12 years of age: 1/2 teaspoonful(2.5 mL) every6 - 8 hours, not to exceed 1 1/2teaspoonfuls in a24 hour period. Children under 6years of age: Consult a doctor
Nasohist Pediatric

Nasohist Pediatric

Administer each dose four times per day using provided dropper.Do not exceed recommended dosage. AGE DOSE* Children 6 to under12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not toexceed 4 doses (8 dropperfuls) per 24 hours,or as directed by a doctor. Children under 6years of age: Consult a physician. *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
Nasohist Dm Pediatric

Nasohist Dm Pediatric

Administer each dose four times per day using provided dropper.Do not exceed recommended dosage AGE DOSE* Children 6 to under 12 years of age: 2 dropperfuls (2 mL) every 4-6 hours, not toexceed 4 doses (8 dropperfuls) per 24 hrs,or as directed by a doctor. Children under6 years of age: Consult a physician. *In mild cases or in particularly sensitive patients, less frequent or reduced doses may be adequate.
Zamicet

Zamicet

Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The usual adult dosage is one tablespoonful (15 mL) every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablespoonfuls.

The usual dosages for children are given by the table below, and are to be given every 4 to 6 hours as needed for pain. These dosages correspond to an average individual dose of 0.20 mL/kg of Zamicet™ (providing 0.135 mg/kg of hydrocodone bitartrate and 4.38 mg/kg of acetaminophen). Dosing should be based on weight whenever possible.
BODY WEIGHT APPROXIMATE AGE DOSE every 4 to 6 hours MAXIMUM TOTAL DAILY DOSE(6 doses per day) 12 to 15 kg(27 to 34 lbs) 2 to 3 years 2.8 mL (approx.½ teaspoonful) 16.8 mL (approx.3¼ teaspoonfuls) 16 to 22 kg(35 to 50 lbs) 4 to 6 years 3.75 mL (approx.¾ teaspoonful) 22.5 mL (approx.4½ teaspoonfuls) 23 to 31 kg(51 to 69 lbs) 7 to 9 years 5.6 mL (approx.1 teaspoonful) 33.6 mL (approx.6½ teaspoonfuls) 32 to 45 kg(70 to 100 lbs) 10 to 13 years 7.5 mL (approx.1½ teaspoonfuls) 45 mL (approx.9 teaspoonfuls) 46 kg and up(101 lbs and up) 14 years to adult 11.25 mL (approx.2¼ teaspoonfuls) 67.5 mL (approx.13½ teaspoonfuls)
The total daily dosage for children should not exceed 6 doses per day. It is of utmost importance that the dose of Zamicet™ be administered accurately. A household teaspoon or tablespoon is not an adequate measuring device, especially when one-half or three-fourths of a teaspoonful is to be measured. Given the inexactitude of the household spoon measure and the possibility of using a tablespoon instead of a teaspoon, which could lead to overdosage, it is strongly recommended that caregivers obtain and use a calibrated measuring device. Health care providers should recommend a dropper that can measure and deliver the prescribed dose accurately, and instruct caregivers to use extreme caution in measuring the dosage.
Arbinoxa

Arbinoxa

Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).

Carbinoxamine maleate should be taken on an empty stomach with water.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily.

Clinical experience suggests the following dosage schedules:

Oral Solution: Usual Adult Dosage: 1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily

Usual Child’s Dosage (approximately 0.2 – 0.4 mg/kg/day divided into 3 to 4 doses): Six to eleven years – ½ to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily.

Dosing for children 2 to 5 years of age should be based on weight whenever possible. The usual dosage for children 2 to 5 years of age is approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. In general, this corresponds to a dose of ¼ to ½ teaspoonful (1 to 2 mg) 3 to 4 times daily.
Arbinoxa

Arbinoxa

Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).

Carbinoxamine maleate should be taken on an empty stomach with water.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily.

Clinical experience suggests the following dosage schedules:

Tablets

Usual Adult Dosage:
1 or 2 tablets (4 to 8 mg) 3 to 4 times daily
Usual Child's Dosage:
Six to eleven years—1/2 to 1 tablet (2 to 4 mg) 3 or 4 times daily.
Biclora

Biclora

Do not exceed recommended dosage. Use a calibrated measuring device for administering the drug to a child. Adults and children12 years of ageand over: 2 teaspoonfuls (10 mL) every 6 to 8 hours,not to exceed 6 teaspoonfuls in 24 hours,or as directed by a doctor. Children 6 to under12 years of age: 1 teaspoonful (5 mL) every 6 to 8 hours,not to exceed 3 teaspoonfuls in 24 hours,or as directed by a doctor. Children under 6 years of age: Consult a doctor.
Biclora

Biclora

Do not exceed recommended dosage. Adults and children12 years of ageand over: 1 tablet every 6 to 8hours, not to exceed 3tablets in 24 hours oras directed by a doctor. Children 6 to under12 years of age: 1/2 tablet every 6 to 8 hours, not to exceed 1 1/2tablets in 24 hours, oras directed by a doctor. Children under 6years of age: Consult a doctor.
Biclora-d

Biclora-d

Do not exceed recommended dosage. Adults and children12 years of ageand over: 1 tablet every 6 to 8 hours,not to exceed 3 tablets in 24 hours, or as directedby a doctor. Children 6 to under12 years of age: ½ tablet every 6 to 8 hours,not to exceed 1½ tablets in24 hours, or as directedby a doctor. Children under 6years of age: Consult a doctor.
Biclora-d

Biclora-d

Do not exceed recommended dosage.

Use calibrated measuring device for administering the drug to a child.
Adults and children12 years of ageand over: 2 teaspoonfuls (10 mL) every 6 to 8 hours,not to exceed 6 teaspoonfuls in 24 hours,or as directed by a doctor. Children 6 to under12 years of age: 1 teaspoonful (5 mL) every 6 to 8 hours,not to exceed 3 teaspoonfuls in 24 hours,or as directed by a doctor. Children under 6years of age: Consult a doctor.
Zutripro

Zutripro

Administer ZUTRIPRO® Oral Solution by the oral route only. Measure ZUTRIPRO® Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.9)].

2.1 Adults 18 Years of Age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.
Vituz

Vituz

Administer Vituz Oral Solution by the oral route only. Measure Vituz Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.8)].

2.1 Adults 18 Years of Age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.
Rezira

Rezira

Administer REZIRA Oral Solution by the oral route only. Measure REZIRA Oral Solution with an accurate milliliter measuring device. Do not use a household teaspoon to measure the dose [see Warnings and Precautions (5.9)].

2.1 Adults 18 Years of Age and Older

5 mL every 4 to 6 hours as needed, not to exceed 4 doses (20 mL) in 24 hours.

Hawthorn Pharmaceuticals, Inc.

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Hawthorn Pharmaceuticals, Inc. Drugs