COLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]

COLD AND ALLERGY (PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE) TABLET [ALLEGIANT HEALTH]
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NDC 69168-302-93
Set ID 439b0113-2b2b-4369-b019-1437e5720f7c
Category HUMAN OTC DRUG LABEL
Packager Allegiant Health
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Active ingredient

    Phenylephrine HCl 10 mg
    Chlorpheniramine maleate 4mg

  • Purpose

    Nasal Decongestant
    Antihistamine

  • Uses

    temporarily relieves nasal congestion due to the common cold, and these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • sinus congestion and pressure
  • Warnings

    Do Not Use

    if you are now taking a prescription monoamine oxadise 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
    • trouble urinating due to an enlarged prostate gland
    • diabetes
    • heart disease
    • high blood pressure
    • thyroid disease

    Ask a doctor or pharmacist before use if you are

    taking sedatives or tranquilizers

    When using this product

    • do not use more than directed
    • may cause excitability, especially in children
    • may cause drowsiness; alcohol, sedatives or tranquilizers may increase drowsiness 
    • avoid alcoholic beverages and 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.

  • Keep Out of Reach of Children

    In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms

  • Directions

    Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. Do not take more than 6 doses in 24 hours
    Children under 12 years of age: Consult a doctor

  • Other Information

    • store at room temperature
    • do not use if blister unit is torn or open
  • Inactive Ingredients

    colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, pregelatinized starch, sodium starch glycolate, stearic acid

  • Package/Label Principal Display Panel

    Z:\SPL-OTC Mono\Allegiant Health\Cold and Allergy\LB1091.jpg
  • INGREDIENTS AND APPEARANCE
    COLD AND ALLERGY 
    phenylephrine hcl and chlorpheniramine maleate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-302
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorWHITEScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code T127
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69168-302-931 in 1 CARTON12/23/2014
    124 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34112/23/2014
    Labeler - Allegiant Health (079501930)

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