MAR-COF BP (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SYRUP [MARNEL PHARMACEUTCALS, INC.]

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  • MAR-COF BP (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SYRUP [MARNEL PHARMACEUTCALS, INC.]

MAR-COF BP (BROMPHENIRAMINE MALEATE, CODEINE PHOSPHATE, AND PSEUDOEPHEDRINE HYDROCHLORIDE) SYRUP [MARNEL PHARMACEUTCALS, INC.]
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NDC 0682-0480-16
Set ID 7bef7c48-f784-49c7-a6e6-93042252d54b
Category HUMAN OTC DRUG LABEL
Packager Marnel Pharmaceutcals, Inc.
Generic Name
Product Class alpha-Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each teaspoonful (5 mL))Purpose
    Brompheniramine Maleate 2mgAntihistamine
    Codeine Phosphate 7.5 mgAntitussive (cough suppressant)
    Pseudoephedrine HCl 30mgNasal Decongestant
  • Uses

    temporarily relieves these symptoms due to cold, hay fever or other upper respiratory allergies.

    • runny nose, sneezing, itching of the nose or throat, and itchy watery eyes
    • cough due to minor throat and bronchial irritation
    • nasal congestion
  • Warnings

    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 your doctor before use if you have

    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • chronic pulmonary disease or shortness of breath
    • giving to a child who is taking other drugs

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dosage
    • giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.

    When using this product

    • may cause excitability especially in children
    • may cause or aggravate constipation
    • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • avoid alcoholic beverages while taking this product
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • you get nervous, dizzy, or sleepless
    • symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.

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

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

  • Directions

    • do not exceed 6 doses in 24 hours
    Adults and children 12 years and overtwo teaspoonfuls
    (10 mL) every 4-6 hours
    Children 6 to under 12 years of ageone teaspoonful
    (5mL) every 4-6 hours
    Children under 6 years of ageConsult a doctor
  • Other information

    Each teaspoonful contains 5mg of sodium. Store at controlled room temperature 15°-30°C (59°-86°F).

  • Inactive ingredients

    Apricot Flavor, Citric Acid, D&C Yellow #10, FD&C Red #40, Glycerin, Magnasweet 110, Menthol Flavor, Orange Flavor, Pineapple Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 0682-0480-16
    MARNEL

    Mar-cof®BP

    Antihistamine/
    Antitussive (cough suppressant)/
    Nasal Decongestant

    Each 5mL (one teaspoonful) for oral
    administration contains:

    CV

    Brompheniramine
    Maleate    		2 mg
    Codeine Phosphate7.5 mg
    Pseudoephedrine
    Hydrochloride    		30 mg

    Alcohol-Free / Sugar-Free

    TAMPER EVIDENT:
    Do not use if imprinted safety seal
    under cap is broken or missing.

    Manufactured for:
    Marnel Pharmaceutical, Inc.
    206 Luke Street
    Lafayette, LA 70506

    Rev. 06/09

    16 fl. oz. (473 mL)

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAR-COF BP 
    brompheniramine maleate, codeine phosphate, and pseudoephedrine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0682-0480
    Route of AdministrationORALDEA ScheduleCV    
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 5 mL
    CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J) CODEINE PHOSPHATE7.5 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    MENTHOL (UNII: L7T10EIP3A)  
    ORANGE (UNII: 5EVU04N5QU)  
    PINEAPPLE (UNII: 2A88ZO081O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorAPRICOT, MENTHOL, ORANGE, PINEAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0682-0480-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34110/01/2009
    Labeler - Marnel Pharmaceutcals, Inc. (053781795)
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