ALAHIST CF (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]

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  • ALAHIST CF (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]

ALAHIST CF (DEXBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [POLY PHARMACEUTICALS, INC.]
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NDC 50991-784-02, 50991-784-90
Set ID 59774c8a-deaf-53a6-e053-2991aa0a709f
Category HUMAN OTC DRUG LABEL
Packager Poly Pharmaceuticals, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet) Purpose

    Dexbrompheniramine Maleate 2 mg​

    		Antihistamine
    Dextromethorphan Hydrobromide 20 mgCough Supressant
    Phenylephrine HCl 10mgNasal Decongestant

  • USES

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

    •  relieves cough
    •  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 ifyou have

    •  a breathing problem such as emphysema or chronic bronchitis
    •  glaucoma
    •  trouble urinating due to enlargement of the prostate gland
    •  heart disease
    •  high blood pressure
    •  thyroid disease 
    • diabetes

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

    When using this product

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

    Stop use and ask a doctor if
     nervousness, dizziness, or sleeplessness occur
     symptoms do not improve within 7 days or are accompanied by fever

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

  • DIRECTIONS

    Directions

    Adults and children 12 years of age and over1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
    Children 6 to under 12 years of age1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours

  • INACTIVE INGREDIENTS

    Inactive ingredients
    Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Natural Yellow, Pregelatinized Starch, Silicon Dioxide

  • QUESTIONS

    Questions? Comments?
    Call 1-800-882-1041
    Manufactured for:
    Poly Pharmaceuticals
    Huntsville, AL 35763 Rev. 04/17

  • OTHER INFORMATION

    Other information
    Store at 15°-30°C (59°-86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Alahist CF Tablets are light yellow,caplet-shaped, scored tablets, debossed "C" bisect "F" on one side and plain on the other.

  • KEEP OUT OF REACH OF CHILDREN

    ​Keep out of reach of children

    ​​In case of overdose, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Antihistamine

    Cough Suppressant

    Nasal Decongestant

  • PRINCIPAL DISPLAY PANEL

    ALAHISTlabellabelbooklet

  • INGREDIENTS AND APPEARANCE
    ALAHIST CF 
    dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50991-784
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXBROMPHENIRAMINE MALEATE (UNII: BPA9UT29BS) (DEXBROMPHENIRAMINE - UNII:75T64B71RP) DEXBROMPHENIRAMINE MALEATE2 g
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 g
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TURMERIC (UNII: 856YO1Z64F)  
    Product Characteristics
    ColoryellowScore2 pieces
    ShapeOVALSize11mm
    FlavorImprint Code C;F
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50991-784-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/14/2017
    2NDC:50991-784-0212 in 1 BLISTER PACK; Type 0: Not a Combination Product09/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34109/14/2017
    Labeler - Poly Pharmaceuticals, Inc. (198449894)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM, LLC080000294manufacture(50991-784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rainbow Gold Products, Inc800695152repack(50991-784)
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