BROM TAPP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RIJ PHARMACEUTICAL CORPORATION]

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BROM TAPP (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [RIJ PHARMACEUTICAL CORPORATION]
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NDC 53807-529-04, 53807-529-08
Set ID bc29d732-20df-4aed-96b2-df4cadac4abe
Category HUMAN OTC DRUG LABEL
Packager Rij Pharmaceutical Corporation
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active Ingredients (in each 5mL tsp)

    Brompheniramine maleate, USP 1 mg

    Phenylephrine HCl , USP 2.5 mg

  • PURPOSES

    Antihistamine

    Nasal decongestant

  • USES

    • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies associated with sinusitis
    • 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
    • a breathing problem such as emphysema, or chronic bronchitis

    Ask a doctor or pharmacist before use if you are

    • taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • drowsiness may occur
    • 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

    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)
    •
    not a USP elixir
  • 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 
    brompheniramine maleate, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53807-529
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 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:53807-529-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/16/1999
    2NDC:53807-529-08236 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(53807-529)
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