Label: HEALTHMART MUCUS RELIEF FM- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 April 9, 2014

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

  • Active ingredients (in each caplet)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever/Fever reducer

    Cough Suppressant

    Expectorant

    Nasal decongestant

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  • Uses

    • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • headache
    • fever
    • minor aches and pains
    • sinus congestion and pressure
    • temporarily promotes nasal and/or sinus drainage
    • helps loosen (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive.
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  • Warnings

    Liver warning: This product contains acetaminophen. severe liver damage may occur if you take:

    • more than 12 caplets in 24 hours, which is maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Do not use

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • 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

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

    Ask a doctor or pharmacist before use if

    you are taking the blood thinning drug warfarin

    When using this product

    do not use more than directed

    Stop use and ask a doctor if
    • nervousness, dizziness or sleeplessness occur
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • cough comes back, or occurs with rash or persistent headache. 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.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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  • Directions

    • do not take more than directed (see overdose warning)
    • do not take more than 12 caplets in any 24 hour period
    • Adults and children 12 years and older: take 2 caplets every 4 hours.
    • Children under 12 years of age: Do not use
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  • Other information

    • tamper evident: do not use if individual blister units are borken or open
    • store between 15-30oC(59-86oF)
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  • Inactive ingredients

    Colloidal silicon dioxide, croscaramellose sodium, crospovidone, FD&C red 40 aluminum lake, FD&C yellow 6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, stearic acid, talc, titanium dioxide. May contain methacrylic acid copolymer, sodium bicarbonate

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  • PDP

    Health Mart

    compare to Mucinex Fast-MaxTM severe congestion & cold caplets active ingredients

    for ages 12+

    mucus relief FM

    adult severe congestion & cold

    acetaminophen.....pain reliever/Fever reducer

    dextromethorphan HBr.....cough Suppressant

    guaifenesin....expectorant

    phenylephrine HCl.....nasal congestion

    soothing relief for headache, fever, cough, nasal and chest congestion

    thins and loosens mucus

    20 CapletsPDP

    TEXT

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  • INGREDIENTS AND APPEARANCE
    HEALTHMART MUCUS RELIEF FM 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0218
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    May contain METHACRYLIC ACID (UNII: 1CS02G8656)  
    May contain SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Product Characteristics
    Color red Score no score
    Shape capsule Size 19mm
    Flavor Imprint Code G198
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62011-0218-1 2 in 1 CARTON
    1 10 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 04/04/2013
    Labeler - Mckesson (177667227)
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