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Dallergy (Laser Pharmaceuticals, LLC)

Available Formats

Dosage Form Package Information Links
TABLET, CHEWABLE 100 TABLET, CHEWABLE in 1 BOTTLE (16477-152-01) Label Information

Complete Dallergy Information

  • Active Ingredient Section

    Active Ingredients (in each tablet) Chlorcyclizine Hydrochloride 12.5 mg    Phenylephrine Hydrochloride  5 mg


  • Purpose Section

    Antihistamine  Nasal Decongestant


  • Keep Out of Reach of Children Section

    Keep out of reach of children.


  • Indications & Uses Section

    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


  • Warning Section

    Warnings

    Do not exceed recommended dosage.

    Do not use this product if you are now taking a prescription monamine 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  difficulty in urination 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  be careful 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  new symptoms occur

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


  • Pregnant or Breast-Feeding Section

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


  • Dosage and Administration Section

    Directions

    Do not exceed 3 doses in a 24 hour period.

    Adults and children 12 years of age and over: 2 tablets every 6-8 hours, not to exceed 6 tablets in 24 hours.

    Children 6 to under 12 years of age: 1 tablet every 6-8 hours, not to exceed 3 tablets in 24 hours.

    Children 2 to under 6 years of age: 1/2 tablet every 6-8 hours, not to exceed 1-1/2 tablets in 24 hours.

    Children under 2 years of age: Consult a doctor.


  • Inactive Ingredients Section

    Inactive Ingredients

    FD 7 C Blue #2/Indigo Carmine AL, Grape Flavor, Magnesium Stearate, Microcrystalline Cellulose, Mannitol, Sodium Starch Glycolate, Xylitol DC


  • Other Information Section

    Other Information

    Store at 59 - 86 degrees F (15 - 30 degrees C)


  • Questions? Comments? Section

    Questions? Comments?

    Call 1-864-286-8229


  • Package Label Section

    NDC 16477-152-01  Dallergy CHEWABLE TABLETS  New Improved formula  Antihistamine Nasal Decongestant  For Professional Use

    Each tablet contains: Chlorcyclizine HCI... 12.5 mg   Phenylephrine HCI... 5 mg GRAPE FLAVOR Laser 100 Tablets  Rev 9/11  Lot No:   Exp. Date:

     For full prescribing information, see the product foldout.  Store at 59 - 86 degrees F (15 - 30 degrees C)

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

    This bottle is not to be dispensed to the consumer.

    Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

    The labeling for this product includes professional labeling which is not intended for use by the general public.

    WARNING: KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    IN CASE OF OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    LASER   Manufactures for Laser Pharmaceuticals, LLC Greenville, SC 29615

    Laser Dallergy Chew Label

    Laser Dallergy Chew Label 1
    Laser Dallergy Chew 2

  • INGREDIENTS AND APPEARANCE
    DALLERGY 
    chlorcyclizine hydrochloride tablet, chewable
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-152
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORCYCLIZINE HYDROCHLORIDE (UNII: NPB7A7874U) (CHLORIDE ION - UNII:Q32ZN48698) CHLORCYCLIZINE HYDROCHLORIDE 12.5 mg
    PHENYLEPHRINE (UNII: 1WS297W6MV) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color purple (purple) Score 2 pieces
    Shape ROUND (CHEWABLE TABLETS) Size 12mm
    Flavor GRAPE (GRAPE FLAVOR) Imprint Code LAS152
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16477-152-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 11/01/2011
    Labeler - Laser Pharmaceuticals, LLC (614417132)
    Registrant - Laser Pharmaceuticals, LLC (614417132)