Label: MUCAPHED- guaifenesin and phenylephrine hydrochloride tablet, coated 

  • NDC Code(s): 0485-0250-01
  • Packager: EDWARDS PHARMACEUTICALS, INC.
  • 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 03/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS
    (each tablet contains)
    PURPOSE
    Guaifenesin 400 mg Expectorant
    Phenylephrine HCl 10 mg Nasal Decongestant
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  • Uses

    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies (allergic rhinitis) and helps loosen phlegm (mucus) and thin bronchial secretions to:

    • drain bronchial tubes
    • make coughs more productive
    • nasal stuffiness
    • reduces swelling of nasal passages
    • helps decongest sinus openings and passages
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  • Warnings

    • Do not exceed recommended dosage.

    Do not use this product 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
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • cough that is accompanied by excessive phlegm (mucus)

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms are accompanied by a persistent cough for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache
    • if symptoms do not improve within 7 days or accompanied by a fever — These could be signs of a serious condition.

    If pregnant 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.

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  • Directions

    Do not exceed recommended dosage.

    Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours
    Children 6 to under 12 years of age: ½ tablet every 4 hours, not to exceed 3 tablets in 24 hours
    Children under 6 years of age: Consult a doctor.
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  • Other information

    • store between 15°-30° C (59°-86° F)
    • Caution: do not use if imprinted seal under cap is broken or missing
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  • Inactive ingredients

    croscarmellose sodium, hypromellose, lactose, magnesium silicate, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, povidone, silica, sodium Iauryl sulfate, stearic acid, titanium dioxide, and triacetin

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  • Questions? Comments?

    1-800-543-9560

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Edwards Pharmaceuticals, Inc.
    Ripley, MS 38663

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    E

    NDC 00485-0250-01

    MucaphEd

    EXPECTORANT
    NASAL DECONGESTANT

    Each tablet contains:
    Guaifenesin 400 mg
    Phenylephrine HCl 10 mg

    100 Tablets

    Distributed by:
    Edwards Pharmaceuticals, Inc.
    Ripley, MS 38663

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    MUCAPHED 
    guaifenesin and phenylephrine hydrochloride tablet, coated
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0485-0250
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 400 mg
    PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    HYPROMELLOSES  
    LACTOSE  
    MAGNESIUM SILICATE  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    CELLULOSE, MICROCRYSTALLINE  
    MINERAL OIL  
    POVIDONES  
    SILICON DIOXIDE  
    SODIUM LAURYL SULFATE  
    STEARIC ACID  
    TITANIUM DIOXIDE  
    TRIACETIN  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape OVAL Size 18mm
    Flavor Imprint Code PH;0A3
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0485-0250-01 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 09/11/2012
    Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
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