Label: VANATAB DM- dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

  • NDC Code(s): 58809-198-60
  • Packager: GM Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • Active Ingredients

    Each caplet contains:

    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
    • the impulse to cough to help you get to sleep
    • nasal congestion due to a cold
  • Warnings

    Do not use 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 DOCTOR

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a cough that lasts or is chronic such as occurs with smoking
    • asthma, or emphysema
    • a cough that occurs with too much phlegm (mucus)
    • difficulty in urination due to enlargement of the prostate gland
  • WHEN USING

    When using this poduct do not use more than directed

  • Stop use and ask a doctor if:

    • nervousness, dizziness or sleeplessnss occurs
    • sysmtoms 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professhional 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 take more than 6 doses in any 24-hour period
    • dose as follows or as directed by a doctor

    adults and children 12 years of age and over:

    2 caplets every 4 hours
    children 6 to under 12 years of age:1 caplet every 4 hours
    children under 6 years of age:consult a doctor

  • Other information

    • Store at 68-77 oF (20-25 oC).
  • Inactive Ingredients

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

  • Questions or Comments?

    Call 1-888-535-0305 9 a.m. - 5 p.m. CST.

  • PRINCIPAL DISPLAY PANEL

    Distributed by:

    GM Pharmaceuticals

    Arlington, TX 76015

    princpal display labelonsert-1

  • INGREDIENTS AND APPEARANCE
    VANATAB DM 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-198
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN198 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE9 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MENTHOL 1-PROPYLENE GLYCOL CARBONATE, (-)- (UNII: 2WL8FX4EEZ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    Colorwhite (white/off white) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code 19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-198-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2017
    Labeler - GM Pharmaceuticals, Inc. (793000860)
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