VANATAB DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

VanaTab DM by

Drug Labeling and Warnings

VanaTab DM by is a Otc medication manufactured, distributed, or labeled by GM Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 children12 years of ageand over: 2 tablets every 4 hours, not to exceed 6 doses in 24 hours
• Children 6 to under12 years of age: 1 tablet every 4 hours, not to exceed 6 doses in 24 hours
• Children under 6 yearsof 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

INGREDIENTS AND APPEARANCE

VANATAB DM 
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58809-198
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	198 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	9 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LEVOMENTHOL (UNII: BZ1R15MTK7)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	WHITE (white/off white)	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code	19
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58809-198-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/01/2017

Labeler - GM Pharmaceuticals, INC (793000860)