VANACOF

GM Pharmaceuticals
Pernix Manufacturing, LLC

VANACOF DX

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• VANACOF Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • Stop use and ask a doctor if
  • If pregnant or breast-feeding,
  • 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
Guaifenesin 100 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Cough Suppressant
Expectorant
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
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
• 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, chronic bronchitis or emphysema
• a cough that occurs with too much phlegm (mucus)
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
  

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, raspberry flavor, sodium citrate, sodium saccharin, and sorbitol.

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 58809-907-01

VANACOF DX

EACH 5 mL (1 TEASPOONFUL) CONTAINS:

Chlophedianol Hydrochloride....... 12.5 mg
Guaifenesin............................... 100 mg
Pseudoephedrine Hydrochloride.... 30 mg

Cough Suppressant
Expectorant
Nasal Decongestant

Sugar Free, Alcohol Free,
Dye Free

Raspberry 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 76012

Rev. 06/12

Patent Pending