VANATAB DX

GM Pharmaceuticals, Inc.

VANATAB DX

FULL PRESCRIBING INFORMATION: CONTENTS*

• Drug Facts
• Purpose
• VANATAB DX 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
• VANATAB DX Other information
• Inactive ingedients
• Questions? Comments?
• Product Packaging

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients
Chlophedianol Hydrochoride 12.5 mg
Guaifenesin 200 mg
Pseudoephedrine Hydrochloride 30 mg

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

VANATAB DX 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 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
• 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)
  

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur
• cough or nasal congestion persists for more than1 week, tends to recur, or is accompanied by 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.

Directions

VANATAB DX Other information

Store at 59°- 86°F (15°- 30°C)

Inactive ingedients

Dicalcium Phosphate Dihydrate, Croscarmellose Sodium, Silicone Dioxide, Stearic Acid, and Microcrystalline Cellulose

Questions? Comments?

Serious side effects may be reported to this number, call 1-888-535-0305, 8:00 AM - 5:00 PM Monday - Friday, Central time.

Product Packaging

The packaging below represents the labeling currently used.

Principal display panel and side panel for 100 tablets label:

NDC 58809-407-01

VANATAB DX

EACH TABLET CONTAINS:
Chlophedianol Hydrochloride................12.5 mg
Guaifenesin.........................................200 mg
Pseudoephedrine Hydrochloride..............30 mg

Cough Suppressant
Expectorant
Nasal Decongestant

100 Tablets

GM Pharmaceuticals, Inc.
Tamper evident by foil seal under cap.
Do not use if safety band is broken or missing.

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

Patent Pending

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

Rev. 04/11