RU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]

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RU-HIST D (BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [ALLEGIS PHARMACEUTICALS, LLC]
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NDC 28595-900-60
Set ID 1a93fa51-94fb-434b-913f-b2424cf4d968
Category HUMAN OTC DRUG LABEL
Packager Allegis Pharmaceuticals, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients
    Each tablet contains:    		Purpose
    Brompheniramine Maleate 4 mgAntihistamine
    Phenylephrine HCl 10 mgNasal Decongestant
  • Uses

    Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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 a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes mellitus
    • difficulty in urination due to enlargement of the prostate gland

    Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • if symptoms do not improve within 7 days or are accompanied by fever
    • new symptoms occur

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

    Keep out of reach of children.

    In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over:1 tablet every 4 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
    Children 6 to under 12 years of age:1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
    Children under 6 years of age:Consult a doctor
  • Other information

    Store at 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

  • Inactive ingredients

    Magnesium Stearate, Microcrystalline Cellulose, Sodium Starch Glycolate

  • Questions or Comments?

    Call 866-633-9033

  • PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

    NDC 28595-900-60

    Ru-Hist D
    Antihistamine • Nasal Decongestant

    Each tablet contains:
    Brompheniramine Maleate    4 mg
    Phenylephrine HCl    10 mg

    Tamper evident by foil seal under cap. Do not use if foil seal
    is broken or missing.

    New Formula

    ALLEGIS PHARMACEUTICALS

    Manufactured for:
    Allegis Pharmaceuticals, LLC
    Canton, MS 39046

    60 Tablets

    Principal Display Panel - 60 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    RU-HIST D 
    brompheniramine maleate and phenylephrine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28595-900
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Brompheniramine Maleate (UNII: IXA7C9ZN03) (Brompheniramine - UNII:H57G17P2FN) Brompheniramine Maleate4 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride10 mg
    Inactive Ingredients
    Ingredient NameStrength
    Magnesium Stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize14mm
    FlavorImprint Code 300
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28595-900-6060 in 1 BOTTLE; Type 0: Not a Combination Product11/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34111/01/2013
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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