Label: ALAHIST CF- dexbrompheniramine maleate, dextromethorphan hbr, phenylephrine hcl tablet

  • NDC Code(s): 50991-784-02, 50991-784-90
  • Packager: Poly Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 20, 2020

If you are a consumer or patient please visit this version.

  • 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)