CYPROHEPTADINE HYDROCHLORIDE (Page 2 of 2)

DOSAGE AND ADMINISTRATION

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

Each tablet contains 4 mg of cyproheptadine hydrochloride.

Pediatric Patients:
Age 2 to 6 years: The total daily dosage for pediatric patients may be calculated on the basis of body weight or body area using approximately 0.25 mg/kg/day or 8 mg per square meter of body surface (8 mg/m2).

The usual dose is 2 mg (1⁄2 tablet) 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 (1 tablet) 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. 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 (1 tablet) three times a day and adjusted according to the size and response of the patient.

HOW SUPPLIED

Cyproheptadine Hydrochloride Tablets USP are available as white to off white, flat-faced, bevel-edged, round shaped tablets, one side debossed with “CYP”, the other side bisected, containing 4 mg of Cyproheptadine HCl packaged in bottles of 100 tablets, NDC 0463-6080-01

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required).

Store at 20° — 25° C (68° — 77° F) excursions permitted to 15° — 30° C (59° — 86° F) [see USP Controlled Room Temperature]

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Manufactured for: Cypress Pharmaceutical, Inc., Madison, MS 39110

100ct label
(click image for full-size original)
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0463-6080
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE ) CYPROHEPTADINE HYDROCHLORIDE 4 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code CYP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0463-6080-01 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040644 06/15/2010
Labeler — C.O. Truxton, Inc. (011157559)
Establishment
Name Address ID/FEI Operations
Stason Pharmaceuticals, Inc. 807437553 manufacture (0463-6080)

Revised: 04/2014 C.O. Truxton, Inc.

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