VANATAB DX

Dosage form: tablet
Ingredients: Chlophedianol Hydrochloride 12.5mg, Guaifenesin 200mg, Pseudoephedrine Hydrochloride 30mg
Labeler: GM Pharmaceuticals, Inc.
NDC Code: 58809-407

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

VANATAB DX

Drug Facts

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

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

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

Directions Do not exceed recommended dosage.
Adults and children
12 years of age
and over:

2 tablets every
6 hours, not
to exceed 8 tablets in a
24 hour period
Children 6 to under
12 years of age:


1 tablet every
6 hours, not to
exceed 4 tablets in a
24 hour period
Children under
6 years of age:
Consult a physician


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





VANATAB DX 
chlophedianol hydrochloride, guaifenesin, pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-407
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chlophedianol Hydrochloride (Chlophedianol) Chlophedianol Hydrochloride12.5 mg
Guaifenesin (Guaifenesin) Guaifenesin200 mg
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride30 mg
Inactive Ingredients
Ingredient NameStrength
Dibasic Calcium Phosphate Dihydrate 
Croscarmellose Sodium 
Silicon Dioxide 
Stearic Acid 
Cellulose, Microcrystalline  
Product Characteristics
ColorwhiteScore2 pieces
ShapeOVALSize17mm
FlavorImprint CodeVTDX
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-407-01100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/06/201102/28/2015
Labeler - GM Pharmaceuticals, Inc. (793000860)

Revised: 12/2013
 
GM Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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