Label: PREFERRED PLUS CHEST CONGESTION RELIEF  - guaifenesin tablet 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT


    Active ingredient (per tablet)

    Guaifenesin  400mg
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  • Purpose

    Expectorant

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  • Uses

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

    Ask doctor before use if you have

    • persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
    • cough is accompanied by excessive phlegm (mucus)
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  • STOP USE

    Stop use and ask doctor if

    • Symptoms are accompanied by fever, rash or persistent headache
    • cough persists for more than 1 week or tends to recur
    A persistent cough may be a sign of a serious condition. Close
  • PREGNANCY OR BREAST FEEDING

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control

    Center immediately.

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  • Directions

    • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
    • Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
    • Children under 6 years of age: consult a doctor    
    Do not exceed 6 doses in a 24 hour period or as directed by a doctor Close
  • Other Information

    store at 15°-30°C (59°-86°F)

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  • Inactive ingredients

    magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

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  • INGREDIENTS AND APPEARANCE
    PREFERRED PLUS CHEST CONGESTION RELIEF  
    guaifenesin tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:61715-012
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Guaifenesin (Guaifenesin) Guaifenesin 400 mg
    Inactive Ingredients
    Ingredient Name Strength
    MALTODEXTRIN  
    STEARIC ACID  
    SILICON DIOXIDE  
    COPOVIDONE  
    MAGNESIUM STEARATE  
    Product Characteristics
    Color white Score 2 pieces
    Shape OVAL Size 17mm
    Flavor Imprint Code PH063
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61715-012-50 50 in 1 BOTTLE, PLASTIC
    2 NDC:61715-012-01 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 08/01/2012
    Labeler - Kinray (012574513)
    Registrant - Reese Pharmaceutical Co (004172052)
    Establishment
    Name Address ID/FEI Business Operations
    Reese Pharmaceutical Co 004172052 relabel(61715-012), repack(61715-012)
    Establishment
    Name Address ID/FEI Business Operations
    Pharbest 557054835 manufacture(61715-012)
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