Label: MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit

  • 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 December 10, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Mucinex FAST-MAX DAY TIME Severe Cold
    Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Mucinex FAST-MAX NIGHT TIME Cold & Flu
    Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Diphenhydramine HCl 12.5 mgAntihistamine/cough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves these common cold and flu symptoms:
      • cough
      • minor aches and pains
      • headache
      • nasal congestion
      • sore throat
      • runny nose (NIGHT TIME only)
      • sneezing (NIGHT TIME only)
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY TIME only)
    • controls cough to help you get to sleep (NIGHT TIME only)
    • temporarily reduces fever
  • Warnings

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:

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

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • with any other drug containing diphenhydramine, even one used on the skin (NIGHT TIME only)
    • 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
    • diabetes
    • high blood pressure
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • glaucoma (NIGHT TIME only)
    • breathing problems such as emphysema or chronic bronchitis (NIGHT TIME only)
    • 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
    • taking sedatives or tranquilizers (NIGHT TIME only)

    When using this product

    • do not use more than directed
    • excitability may occur, especially in children (NIGHT TIME only)
    • marked drowsiness may occur (NIGHT TIME only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (NIGHT TIME only)
    • avoid alcoholic drinks (NIGHT TIME only)
    • be careful when driving a motor vehicle or operating machinery (NIGHT TIME only)

    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 headache that lasts. 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.

  • 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 of age and older: take 2 caplets every 4 hours
    • children under 12 years of age: do not use
  • Other information

    • store between 20-25°C (68-77°F)
  • Inactive ingredients (Mucinex FAST-MAX DAY TIME Severe Cold)

    croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyvinyl alcohol, povidone, talc, titanium dioxide

  • Inactive ingredients (Mucinex FAST-MAX NIGHT TIME Cold & Flu)

    croscarmellose sodium, crospovidone, FD&C blue no. 1, FD&C blue no. 2, ferric oxide yellow, methacrylic acid – ethyl acrylate copolymer (1:1) type A, mica, microcrystalline cellulose, polyethylene glycols, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

  • Questions?

    1-866-MUCINEX (1-866-682-4639)
    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Dist. by: Reckitt Benckiser, Parsippany, NJ 07054-0224
    Made in England

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    MAXIMUM STRENGTH*

    NDC 63824-557-30

    Mucinex®

    FAST-MAX®

    DAY
    TIME
    SEVERE COLD

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Guaifenesin – Expectorant
    Phenylephrine HCl – Nasal Decongestant

    Relieves Aches, Fever
    & Sore Throat
    Controls Cough
    Relieves Nasal & Chest
    Congestion
    Thins & Loosens Mucus

    20 CAPLETS

    NIGHT
    TIME
    COLD & FLU

    Acetaminophen - Pain Reliever/Fever Reducer
    Diphenhydramine HCl - Antihistamine/
    Cough Suppressant
    Phenylephrine HCl - Nasal Decongestant

    Relieves Aches, Fever
    & Sore Throat
    Controls Cough
    Relieves Nasal Congestion
    Relieves Runny Nose
    & Sneezing

    10 CAPLETS

    FOR AGES 12+

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX DAY TIME SEVERE COLD AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, diphenhydramine hydrochloride, guaifenesin, and phenylephrine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-557
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-557-301 in 1 CARTON
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 BLISTER PACK 20 
    Part 21 BLISTER PACK 10 
    Part 1 of 2
    MUCINEX FAST-MAX DAY TIME SEVERE COLD   MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
    Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ) Guaifenesin200 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (15 MPA.S at 5%) (UNII: 68401960MK)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C yellow no. 6 (UNII: H77VEI93A8)  
    magnesium stearate (UNII: 70097M6I30)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    polyvinyl alcohol (UNII: 532B59J990)  
    povidones (UNII: FZ989GH94E)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;MCS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    12 in 1 CARTON
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2015
    Part 2 of 2
    MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
    acetaminophen, diphenhydramine hydrochloride, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride12.5 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (15 MPA.S at 5%) (UNII: 68401960MK)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    FD&C blue no. 2 (UNII: L06K8R7DQK)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    methacrylic acid - ethyl acrylate copolymer (1:1) type a (UNII: NX76LV5T8J)  
    mica (UNII: V8A1AW0880)  
    cellulose, microcrystalline (UNII: OP1R32D61U)  
    polyethylene glycols (UNII: 3WJQ0SDW1A)  
    polyvinyl alcohol (UNII: 532B59J990)  
    povidone k29/32 (UNII: 390RMW2PEQ)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;SI
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 CARTON
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2015
    Labeler - Reckitt Benckiser LLC (094405024)