Label: BROM TAPP DM- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 30, 2018

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  • Active Ingredients (in each 5mL tsp)

    Brompheniramine maleate, USP 1 mg

    Dextromethorphan HBr, USP 5 mg

    Phenylephrine HCl , USP 2.5 mg

  • PURPOSES

    Antihistamine

    Cough suppressant

    Nasal decongestant

  • USES

    • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
      • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
    • temporarily restores freer breathing through the nose
  • 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 MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
    • glaucoma
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • may cause marked drowsiness
    • avoid alcoholic beverages
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

    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 take more than 6 doses in any 24-hour period
    agedose
    adults and children 12 years and over 4 tsp every 4 hours
    children 6 to under 12 years2 tsp every 4 hours
    children under 6 yearsask a doctor
  • Other Information

    •
    TAMPER EVIDENT: Do not use if breakaway band on cap is broken or missing
    •
    each teaspoon (5 ml) contains: sodium 5 mg
    •
    store at room temperature 15º - 30ºC (59º - 86ºF)
  • INACTIVE INGREDIENTS

    artificial flavor, citric acid, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, sodium benzoate, sodium citrate, sodium saccharin, sorbitol, water

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    BROM TAPP DM 
    brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53807-530-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    2NDC:53807-530-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34103/16/1999
    Labeler - Rij Pharmaceutical Corporation (144679156)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rij Pharmaceutical Corporation144679156manufacture(53807-530)
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