Cyproheptadine Hydrochloride (Page 2 of 2)

DOSAGE AND ADMINISTRATION

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

Although intended primarily for administration to children, the syrup 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 Syrup (Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL) in a yellow, mint-flavored vehicle, is supplied in a pint (473 mL) container NDC 54868-4338-0.

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

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

Manufactured by:
Lyne Laboratories, Inc.
Brockton, MA 02301

Distributed by:
Actavis Mid Atlantic LLC FORM NO. 1400
1877 Kawai Road VC108865
Lincolnton, NC 28092 USA

REV. 10/10

Distributed by:
Physicians Total Care, Inc.
Tulsa, OK 74146

EACH 5 mL (ONE TEASPOONFUL) CONTAINS: Cyproheptadine Hydrochloride 2 mg, Alcohol 5%, Sorbic Acid 0.1% added as preservative.

USUAL DOSAGE: See accompanying package insert.
Store at 20°-25°C (68°-77°F) excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured by:
Lyne Laboratories, Inc.
Brockton, MA 02301
Distributed by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA

Rx Only

Cyproheptadine

Hydrochloride

Syrup

(Cyproheptadine Hydrochloride

Oral Solution, USP)

2 mg/5 mL

One Pint (473mL)

NDC 54868-4338-0

CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride syrup

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4338(NDC:0472-1400) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYPROHEPTADINE HYDROCHLORIDE (CYPROHEPTADINE) CYPROHEPTADINE HYDROCHLORIDE 2 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SUCROSE ALCOHOL SORBIC ACID SODIUM CITRATE ANHYDROUS CITRIC ACID D&C YELLOW NO. 10 WATER

Product Characteristics Color Score Shape Size Flavor MINT (MINT) Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-4338-0 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040668 07/31/2009

Labeler — Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel (54868-4338)

Revised: 07/2013 Physicians Total Care, Inc.