V-COF (Page 2 of 2)

DOSAGE AND ADMINISTRATION

V-COF Suspension: Administer the recommended dose up to four times daily.

CHILDREN

Over 12 years of age — 5 to 10 mL (1 to 2 teaspoonfuls);
6 to 12 years of age — 5 mL (1 teaspoonful);
2 to 6 years of age — 2.5 mL (1/2 teaspoonful);
Under 2 years of age — Consult a physician.

Each 5 mL of V-COF Suspension contains:
6 mg Brompheniramine Maleate, 10 mg Phenylephrine HCl and 25 mg Carbetapentane Citrate in a suspension.

Note: The Hydrochloride salt of Phenylephrine, the Maleate salt of Brompheniramine, and the Citrate salt of Carbetapentane are provided by means of a patented manufacturing process.

HOW SUPPLIED

V-COF Suspension: (Phenylephrine HCl 10 mg, Brompheniramine Maleate 6 mg, and Carbetapentane Citrate 25 mg per 5 mL) is available in a Bubble Gum-flavored suspension in 4 fl. oz. bottles NDC No.: 44183- 514-04.

Store at controlled room temperature, 20°-25°C (68°-77°F).

Dispense in a tight, light resistant container (USP/NF) with a child-resistant closure.

Patent protected.

Rx Only

Manufactured for:
Macoven Pharmaceuticals
Magnolia, TX 77354

Rev. 12/09
541-64314-0

PRINCIPAL DISPLAY PANEL — 118 mL Bottle Label

Antihistamine • Decongestant • Antitussive

NDC 44183-514-04

V-COF
Suspension

Each Teaspoonful (5 mL) Contains:
Brompheniramine Maleate6 mg
Phenylephrine HCl10 mg
Carbetapentane Citrate25 mg

Shake Well
4 fl oz (118 mL)

Rx Only

PRINCIPAL DISPLAY PANEL -- 118 mL Bottle Label
(click image for full-size original)
V-COF
brompheniramine maleate, phenylephrine hydrochloride, and carbetapentane citrate suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:44183-514
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brompheniramine maleate (BROMPHENIRAMINE) brompheniramine maleate 6 mg in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 5 mL
CARBETAPENTANE CITRATE (CARBETAPENTANE) CARBETAPENTANE CITRATE 25 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME
ASPARTAME
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
GLYCERIN
METHYLPARABEN
MAGNESIUM ALUMINOMETASILICATE TYPE I-A
WATER
SODIUM BENZOATE
SODIUM CITRATE
XANTHAN GUM
TANNIC ACID
Product Characteristics
Color RED (LIGHT RED) Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44183-514-04 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/04/2010
Labeler — Macoven Pharmaceuticals (832591965)

Revised: 12/2010 Macoven Pharmaceuticals

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