VANACOF

GM Pharmaceuticals
Pernix Manufacturing, LLC

VANACOF

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• VANACOF Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • Ask a doctor before use if you are
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• VANACOF Other information
• Inactive ingredients
• Questions? Comments?
• PRODUCT PACKAGING:

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients                             
(in each 5 mL teaspoonful)
Chlophedianol Hydrochloride 12.5 mg
Dexchlorpheniramine Maleate 1 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Cough Suppressant
Antihistamine
Nasal Decongestant

VANACOF Uses

Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• cough due to minor throat and bronchial irritation
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes
• nasal congestion
• reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do not use this product

• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
  

Ask a doctor before use if you have

• a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
• a cough that occurs with too much phlegm (mucus)
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland
• heart disease
• high blood pressure
• thyroid disease
• diabetes

Ask a doctor before use if you are

taking sedatives or tranquilizers.

When using this product

• excitability may occur, especially in children
• may cause marked drowsiness
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase the drowsiness effect
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

VANACOF Other information

Store at 59° - 86°F (15° - 30°C)

Inactive ingredients

citric acid, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol, and tutti frutti flavor.

Questions? Comments?

Serious side effects may be reported to this number, call 1-888-535-0305 (8 am to 5 pm).

PRODUCT PACKAGING:

The packaging below represents the labeling currently used:

Principal Display Panel and Side Panel for 473 mL Label:

NDC 58809-999-01

VANACOF^®

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol Hydrochloride..... 12.5 mg
Dexchlorpheniramine Maleate....... 1 mg
Pseudoephedrine Hydrochloride... 30 mg

Cough Suppressant
Antihistamine
Nasal Decongestant
Sugar Free, Alcohol Free,
Dye Free

Tutti Frutti Flavor

16 fl. oz. (473 mL)

GM Pharmaceuticals, Inc.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

THIS BOTTLE IS NOT TO BE DISPENSED TO CONSUMER.

Dispense in a tight, light-resistant container with a child-resistant cap.

Distributed by:
GM Pharmaceuticals, Inc.
Arlington, TX 76015

Rev. 12/03/13

Patent Pending