BROTAPP PE-DM COUGH AND COLD LIQUID [LANNETT COMPANY, INC.]

BROTAPP PE-DM COUGH AND COLD LIQUID [LANNETT COMPANY, INC.]
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NDC 54838-147-40, 54838-147-70
Set ID 9078e8dc-7e9c-4748-84b6-f3ffee2a6620
Category HUMAN OTC DRUG LABEL
Packager Lannett Company, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Drug Facts                                                      Purpose

    Active ingredients ( in each 5 mL)                                                            

    • Brompheniramine maleate 1 mg                         Antihistamine
    • Phenylephrine hydrochloride 2.5 mg                   Nasal Decongestant
    • Dextromethorphan hydrobromide 5 mg               Cough Suppressant
  • PURPOSE

    Drug Facts                                                      Purpose

    Active ingredients ( in each 5 mL)                                                            

    • Brompheniramine maleate 1 mg                         Antihistamine
    • Phenylephrine hydrochloride 2.5 mg                   Nasal Decongestant
    • Dextromethorphan hydrobromide 5 mg               Cough Suppressant
  • INDICATIONS & USAGE


    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, or associated with sinusitis
    • temporarily relieves 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 in a child under 6 years of age

    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
    •  glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • breathing problem or persistent or chronic cough that lasts or as occurs with smoking, asthma, emphysema, or chronic bronchitis
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use

    • if you are taking sedatives or tranquilizers
  • WHEN USING

    When using this product

    • do not use more than directed

    • marked 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


    Stop use and ask a doctor if
    •  you get nervous, dizzy, or sleepless
    • symptoms do not improve 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.
  • PREGNANCY

    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.
  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than 6 doses in any 24-hour period

     Adults and children 12 years and over
     4 teaspoonfuls every 4 hours
     Children 6 to under 12 years
     2 teaspoonfuls every 4 hours
     Children under 6 years
     DO NOT USE
  • STORAGE AND HANDLING

    Other information

    • Store at 20°-25°C (68°-77°F).
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • QUESTIONS

    Questions 

    888-974-5279

    Manufactured by

    Silarx Pharamceuticals. Inc
    19 West Steet
    Spring Vally, NY-10977, USA.

  • PRINCIPAL DISPLAY PANEL


    Container Label 118mL

    ontainer Label 237mL


  • INGREDIENTS AND APPEARANCE
    BROTAPP PE-DM COUGH AND COLD 
    brotapp pe-dm cough and cold liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54838-147
    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
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPE (Grape Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54838-147-40118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2001
    2NDC:54838-147-70237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34104/02/2001
    Labeler - Lannett Company, Inc. (161630033)

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