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Reese ONETAB Congestion and cough (Reese Pharmaceutical Co)

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TABLET 1 BOTTLE, PLASTIC in 1 CARTON (10956-814-01) > 30 TABLET in 1 BOTTLE, PLASTIC (10956-814-30) Label Information

Complete Reese ONETAB Congestion and cough Information

  • ACTIVE INGREDIENT

    Guaifenesin                             400 mg

    Phenylephrine HCl                   10 mg


  • PURPOSE

    Guaifenesin                               Expectorant

    Phenylephrine HCl                   Nasal decongestant


  • INDICATIONS & USAGE

    temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

    helps loosen phlegm;mucus

    clear nasal passageways

    loosens nasal congestion

    drain bronchial tubes

    shrinks swollen membranes

    clears stuffy nose

    makes coughs more productive


  • WARNINGS

    do not exceed recommended dosage


  • DO NOT USE

    Do not use this product if you are now taking a prescription Monoamine Oxidase inhibitor ; MAIO,

    certain drugs for depression,psychiatric or emotional conditions, or Parkinsons Disease or for 2 weeks

    after stopping the MAIO drug,if you are uncertain whether your prescription contains an MAIO ,

    ask a health professional.


  • ASK DOCTOR

    ask a doctor before use if you have

    heart disease

    high blood pressure

    thyroid disease

    diabetes

    excessive phlegm;mucus

    difficulty in urination due to an enlarged prostate gland

    persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema


  • STOP USE

    stop use and ask a doctor if

    nervousness,dizziness or sleeplessness occurs

    symptoms are accompanied by fever,rash,persistent headache or excessive phlegm;mucus.

    cough and congestion do not approve within 7 days or tend to recur

    these could be signs of a serious condition


  • PREGNANCY 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 immediately.


  • DOSAGE & ADMINISTRATION

    directions

    Adults and Children 12 years of age and over take 1 caplet every 4 hours as needed

    children 6 to under 12 years of age consult a doctor

    do not exceed 6 doses in a 24 hour period or as directed by a doctor.


  • INACTIVE INGREDIENT

    croscarmellose sodium,hypromellose,lactose,magnesium silicate,

    magnesium stearate,maltodextrin,mycocrystalline cellulose,mineral oil,povidone,

    silica,sodium lauryl sulfate,stearic acid,titanium oxide and triacetin.


  • INGREDIENTS AND APPEARANCE
    REESE ONETAB CONGESTION AND COUGH 
    guaifenesin/phenylephrine tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:10956-814
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin 400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POVIDONE (UNII: FZ989GH94E)  
    MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL Size 17mm
    Flavor Imprint Code RCCGPE;C27
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:10956-814-01 1 in 1 CARTON
    1 NDC:10956-814-30 30 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 06/01/2010
    Labeler - Reese Pharmaceutical Co (004172052)
    Establishment
    Name Address ID/FEI Business Operations
    Reese Pharmaceutical Co 004172052 relabel, repack