ALLERFED COLD AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]

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  • ALLERFED COLD AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]

ALLERFED COLD AND ALLERGY (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-966-24
Set ID a5542213-0dc9-4eae-b7cb-e7e153b38bd8
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each tablet)

    Chlorpheniramine maleate 4 mg
    Phenylephrine HCl 10 mg

  • Purpose

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other respiratory allergies:
      • runny nose
      • itchy, watery eyes
      • itching of the nose or throat
      • sneezing
      • nasal congestion
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • sneezing
      • nasal congestion
  • Warnings

    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 a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers.

    When using this product

    • do not exceed recommended dose
    • drowsiness may occur
    • avoid alcoholic drinks
    • 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 and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or occur with a fever

    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.

  • Directions

    • adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
    • children under 12 years: do not use this product in children under 12 years of age
  • Other information

    • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, silica gel, stearic acid

  • Questions or comments?

    1-800-426-9391

  • Principal Display Panel

    QC
    QUALITY®
    CHOICE

    NDC 63868-966-24

    Allerfed
    Cold & Allergy

    Chlorpheniramine maleate 4 mg / Antihistamine
    Phenylephrine HCl 10 mg / Nasal Decongestant

    Relieves:
    Nasal Congestion, Runny Nose, Sneezing & Itchy, watery eyes

    24 Tablets (One Tablet Dose)             Actual Size

    TAMPER EVIDENT: DO NOT USE IF
    CARTON IS OPENED OR IF BLISTER
    UNIT IS TORN, BROKEN OR SHOWS
    ANY SIGNS OF TAMPERING

    50844     ORG061252508

    SATISFACTION
    100%
    QC
    GUARANTEED

    Distributed by C.D.M.A., Inc.©
    43157 W. Nine Mile
    Novi, MI 48376-0995
    www.qualitychoice.com
    Questions: 248-449-9300

    Quality Choice 44-525

    Quality Choice 44-525

  • INGREDIENTS AND APPEARANCE
    ALLERFED  COLD AND ALLERGY
    chlorpheniramine maleate, phenylephrine hcl tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-966
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code 44;525
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-966-241 in 1 CARTON07/22/200507/10/2022
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/22/200507/10/2022
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(63868-966)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(63868-966)
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