VANACOF

GM Pharmaceuticals, Inc.
Pernix Manufacturing, LLC

VANACOF APE

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
  • Purpose
• VANACOF Uses
• Warnings
  • Do not use this product
  • Ask a doctor before use if you have
  • 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 15 mL (TBSP))
Chlophedianol HCl 25 mg
Phenylephrine HCl 10 mg
Thonzylamine HCl 50 mg

Purpose

Cough Suppressant
Nasal Decongestant
Antihistamine

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
• nasal congestion
• reduces swelling of nasal passages
• runny nose
• sneezing
• itching of the nose or throat
• itchy, watery eyes

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)
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to an enlarged prostate gland
• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
  

Ask a doctor or pharmacist 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

·Each 15 mL (TBSP) contains:  Sodium 7 mg.
·Store at 59° to 86°F (15° to 30°C).

Inactive ingredients

Bitter Mask, FD&C Blue #1, Glycerin, Maltitol, Propylene Glycol, Purified Water, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

Call 1-888-535-0305

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 118 mL label:

NDC 58809-247-04

VANACOF^® APE

Each 15 mL (TBSP) contains:
Chlophedianol HCl......................25 mg
Phenylephrine HCl......................10 mg
Thonzylamine HCl......................50 mg

Cough Suppressant
Nasal Decongestant · Antihistamine

Tutti Frutti Flavor

Alcohol Free / Sugar Free / Gluten Free

4 fl oz. (118 mL)

GM Pharmaceuticals, Inc.

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

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

Distributed by:  GM Pharmaceuticals, Inc.
                       Arlington, Tx  76012

Patent Pending                          Iss. 07/12