Cyproheptadine Hydrochloride (Page 2 of 2)

DOSAGE AND ADMINISTRATION

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

Each 5 mL of Cyproheptadine Hydrochloride Oral Solution contains 2 mg of Cyproheptadine hydrochloride.

Although intended primarily for administration to children, the oral solution is also used for administration to adults who cannot swallow tablets.

Children

The total daily dosage for children may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day (0.11 mg/lb/day) or 8 mg per square meter of body surface (8 mg/m2).

Age 2 to 6 years

The usual dose is 2 mg (one teaspoonful) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 12 mg a day.

Age 7 to 14 years

The usual dose is 4 mg (two teaspoonsful) two or three times a day, adjusted as necessary to the size and response of the patient. The dose is not to exceed 16 mg a day.

Adults

The total daily dose for adults should not exceed 0.5 mg/kg/day (0.23 mg/lb/day). The therapeutic range is 4 to 20 mg a day, with the majority of patients requiring 12 to 16 mg a day. An occasional patient may require as much as 32 mg a day for adequate relief. It is suggested that dosage be initiated with 4 mg (two teaspoonsful) three times a day and adjusted according to the size and response of the patient.

HOW SUPPLIED

Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL in a yellow, peppermint-flavored vehicle, is supplied in a 473 mL (16 FL. OZ.) bottle.

Store at 20-25°C (68-77°F). Excursion permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

NDC#39328-544-16 473 mL (16 FL. OZ.)

Manufactured for:
Patrin Pharma
Skokie, IL 60076

(800) 936 3088

Rev 01.0122

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

Rx Only

NDC
39328-544-16

Cyproheptadine
Hydrochloride
Oral Solution,
USP

2 mg/5 mL

473 mL (16 FL. OZ.)

PATRIN
PHARMA

PRINCIPAL DISPLAY PANEL -- 473 mL Bottle Label
(click image for full-size original)
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39328-544
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cyproheptadine (Cyproheptadine) Cyproheptadine 2 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
ANHYDROUS CITRIC ACID
D&C YELLOW NO. 10
PEPPERMINT
WATER
TRISODIUM CITRATE DIHYDRATE
SORBIC ACID
SUCROSE
Product Characteristics
Color YELLOW Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:39328-544-16 473 mL in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209108 02/15/2022
Labeler — Patrin Pharma, Inc. (806841677)

Revised: 02/2022 Patrin Pharma, Inc.

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