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VanaTab DM

Medically reviewed on September 21, 2017

Dosage form: tablet
Ingredients: GUAIFENESIN 198mg, DEXTROMETHORPHAN HYDROBROMIDE 9mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: GM Pharmaceuticals, INC
NDC Code: 58809-198

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 DM

VANATAB DM

Drug Facts

Active ingredients

(in each tablet) 
Dextromethorphan HBr 9 mg 
Guaifenesin 198 mg 
Phenylephrine HCl 5 mg 

Purpose

Cough Suppressant 
Expectorant 
Nasal Decongestant 

Uses
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
  • temporarily relieves:
  • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • the intensity of coughing
  • nasal congestion due to a cold

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 last 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
  • symptoms do not improve within 7 days or are 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

Do not exceed recommended dosage.

Adults and children
12 years of age
and over:
2 tablets every 4 hours, not to exceed 6 doses in 24 hours
Children 6 to under
12 years of age:
1 tablet every 4 hours, not to exceed 6 doses in 24 hours
Children under 6 years
of age:
Consult a doctor.

Other information
  • store at Controlled Room Temperature 68°- 86°F (20°- 30°C) with permitted excursions of 59° – 86°F (15° – 30°C) 
  • Tamper evident mby foil seal under cap. Do not use if foil seal is broken or missing.

Inactive ingredients

magnesium stearate, menthol, microcrystalline cellulose, polyethylene glycol, polysorbate, polyvinyl alcohol, pregelatinized starch, silicon dioxide, talc

Questions? Comments?

Call 1-888-535-0305 9a.m. – 5p.m. CST


Manufactured for:
GM Pharmaceuticals, Inc.
Arlington, TX

PRINCIPAL DISPLAY PANEL

NDC 58809-198-60
VanaTab DM
60 Tablets

VANATAB DM 
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-198
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN198 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE9 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL, UNSPECIFIED 
STARCH, PREGELATINIZED CORN 
SILICON DIOXIDE 
TALC 
CROSCARMELLOSE SODIUM 
MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- 
MICROCRYSTALLINE CELLULOSE 
Product Characteristics
ColorWHITE (white/off white) Scoreno score
ShapeOVALSize15mm
FlavorImprint Code19
Contains    
Packaging
#Item CodePackage Description
1NDC:58809-198-6060 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2017
Labeler - GM Pharmaceuticals, INC (793000860)

 
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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