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Respaire-30 (Laser Pharmaceuticals, LLC)

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CAPSULE 100 CAPSULE in 1 BOTTLE (16477-306-01) Label Information

Complete Respaire-30 Information

  • Active Ingredient Section

    Drug facts

    Active ingredients (in each immediate-release capsule) Guaifensin 150 mg  Pseudoephedine HCL 30mg


  • Purpose Section

    Purpose  Expectorant  Nasal decongestant


  • Keep Out of Reach of Children Section

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


  • Indications and Uses Section

    Uses

    helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

    temporarily relieves nasal congestion due to :  the common cold  hay fever  upper respiratory allergies  temporarily restores free breathing through the nose  promotes nasal and /or sinus drainage  temporarily relieves sinus congestion and pressure


  • Warning Section

    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

    heart disease  diabetes  high blood pressure   thyroid disease  trouble urinating due to enlarged prostate gland  persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema  cough accompanied by too much phlegm (mucus)

    When using this product do not use more than directed

    Stop use and ask a doctor if

    you get nervous, dizzy or sleepless  symptoms do not get better within 7 days, come back or occur with fever, rash or persistant headache. These could be signs of a serious illness.


  • Dosage and Administration Section

    Directions

    take with a full glass of water  this product can be administered without regard for timing of meals

    adults and children 12 years of age and older  1 or 2 capsules every 4-6 hours: not more than 8 capsules in 24 hours

    children 6 to under 12 years of age  1 capsule every 4-6 hours: not more than 4 capsules in 24 hours

    children under 6 years of age  do not use


  • Inactive Ingredient Section

    Inactive ingredients

    corn starch, DandC yellow #10,FDandC blue #!, FDandC red #$), gelatin, iron oxide back, povidone, shellac, sugar, talc, titanium dioxide


  • Pregnancy or Breast-Feeding Section

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


  • Other Information Section

    Other information

    store at 25 degrees C (77 degrees) excursions permitted between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

    use by expiration date on package


  • Questions Section

    Questions? call 1-864-286-8229, 24 hours a day


  • Package Display Label

    LASER NDC 16477-306-01  Respaire-30  Immediate-Release Capsules

    Guaifensin 150 mg  Pseudoephedrine Hydrochloride 30 mg 

    NASAL DECONGESTANT  EXPECTORANT  Clears Nasal/Sinus Congestion  Thins and Loosens Mucus

    100 CAPSULES

    TAMPER EVIDENT:  DO NOT USE THIS PRODUCT IF THE IMPRINTED FOIL SEAL OVER THE MOUTH OF THE BOTTLE IS CUT, TORN, BROKEN, OR MISSING

    Manufactured by: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735  308T  0309

    Manufactured for Laser Pharmaceuticals, LLC Grenville, SC 29615  Lot #:      Exp. Date: 

      PEEL HERE FOR MORE DRUG FACTS  STOP PEELING


    Respaire-30 Label

    Respaire-30 Label 1



  • INGREDIENTS AND APPEARANCE
    RESPAIRE-30 
    guaifenesin capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:16477-306
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 150 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (CHLORIDE ION - UNII:Q32ZN48698) PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POVIDONE (UNII: FZ989GH94E)  
    SHELLAC (UNII: 46N107B71O)  
    SUCROSE (UNII: C151H8M554)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color green (clear body with an opaque light green cap) Score no score
    Shape CAPSULE (Capsule) Size 19mm
    Flavor Imprint Code LASER360
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:16477-306-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 09/02/2008
    Labeler - Laser Pharmaceuticals, LLC (614417132)
    Registrant - Laser Pharmaceuticals, LLC (614417132)