TUSSLIN TR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS]

TUSSLIN TR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) TABLET [KRAMER NOVIS]
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NDC 52083-617-10
Set ID d38d627e-441f-49f6-b05d-75750944e97d
Category HUMAN OTC DRUG LABEL
Packager KRAMER NOVIS
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredients(in each tablet): Guaifenesin 388 mg, dextromethorphan hydrobromide 28 mg, phenylephrine hydrochloride 10 mg

  • PURPOSE

    Cough Suppressant, Expectorant, Nasal Decongestant

  • INDICATIONS & USAGE

    Uses • temporarily relieves cough due to minor throat or bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive • temporarily relieves nasal congestion due to a cold, hay fever or other respiratory allergies, reduces swelling of nasal passages; shrinks swollen membranes

  • WARNINGS

    Warning • Do not use if you are 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 if you have • diabetes • heart disease • Thyroid disease • high blood pressure • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    When using this product do not use more than directed.

    Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts more than 7 days, comes back, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Hypromellose Maltodextrin, Microcrystalline Cellulose, Polyethylene Glycol / Macrogol, Povidone, Sodium Starch Glycolate, Stearic Acid

  • DOSAGE & ADMINISTRATION

    Directions • do not exceed recommended doses in a 24 hour period.

    • Adults and Children 12 years of age and over. 1 tablet every 6-8 hours. Do not exceed 4 tablets in 24 hours.

    • Children 6 to under 12 years of age: 1⁄2 tablet every 6-8 hours.  Do not exceed 2 tablets in 24 hours.

    • Children under 6 years of age: ask physician.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    TUSSLIN TR 
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-617
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeOVALSize17mm
    FlavorImprint Code tr
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52083-617-10100 in 1 BOTTLE; Type 0: Not a Combination Product05/04/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/04/2015
    Labeler - KRAMER NOVIS (090158395)
    Registrant - KRAMER NOVIS (090158395)

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