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  5. Label Information: Vanatab Dm

FDA Label for Vanatab Dm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS? COMMENTS?
    14. PRINCIPAL DISPLAY PANEL

Vanatab Dm Product Label

The following document was submitted to the FDA by the labeler of this product Gm Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.