Label: MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU MAXIMUM STRENGTH- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, acetaminophen, and diphenhydramine 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 5, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each caplet)
    Mucinex FAST-MAX DAY TIME Severe Congestion & Cough    		Purposes
    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 25 mgAntihistamine
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

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

    Liver warning (NIGHT TIME only)

    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 that contain acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Sore throat warning (NIGHT TIME only): 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. (NIGHT TIME only)
    • 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.
    • for children under 12 years of age

    Ask a doctor before use if you have

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

    Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin (NIGHT TIME only)
    • taking sedatives or tranquilizers (NIGHT TIME only)

    When using this product do not use more than directed. In addition, for NIGHT TIME only:

    • excitability may occur, especially in children
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not get better within 7 days or occur with a fever (DAY TIME only)
    • pain, nasal congestion, or cough gets worse, or lasts more than 7 days (NIGHT TIME only)
    • fever gets worse, or lasts more than 3 days (NIGHT TIME only)
    • redness or swelling is present (NIGHT TIME only)
    • new symptoms occur (NIGHT TIME only)
    • cough comes back, or occurs with fever, 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. In case of overdose, get medical help or contact a Poison Control Center right away.

    Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage. (NIGHT TIME only)

    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 Congestion & Cough)

    croscarmellose sodium, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, methacrylic acid-ethyl acrylate copolymer, mica, microcrystalline cellulose, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, povidone K29/32, sodium bicarbonate, talc, titanium dioxide

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

    corn starch, croscarmellose sodium, crospovidone, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, stearic acid, titanium dioxide, triacetin

  • 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 63824-555-30

    Mucinex®
    FAST-MAX®

    DAY
    TIME

    Severe Congestion
    & Cough

    Dextromethorphan HBr • Cough Suppressant
    Guaifenesin • Expectorant
    Phenylephrine HCl • Nasal Decongestant

    ✓ Controls Cough
    ✓ Relieves Nasal &
    Chest Congestion
    ✓ Thins & Loosens Mucus

    AGES 12+

    20 CAPLETS

    NIGHT
    TIME
    Cold & Flu

    Acetaminophen • Pain Reliever/Fever Reducer
    Diphenhydramine HCl • Antihistamine
    Phenylephrine HCl • Nasal Decongestant

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

    10 CAPLETS

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MUCINEX FAST-MAX DAY TIME SEVERE CONGESTION AND COUGH AND MUCINEX FAST-MAX NIGHT TIME COLD AND FLU   MAXIMUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, acetaminophen, and diphenhydramine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-555
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-555-301 in 1 CARTON04/25/2014
    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 CONGESTION AND COUGH   MAXIMUM STRENGTH
    dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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)  
    FD&C Blue No. 2 (UNII: L06K8R7DQK)  
    aluminum oxide (UNII: LMI26O6933)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    mica (UNII: V8A1AW0880)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    polysorbate 80 (UNII: 6OZP39ZG8H)  
    polyvinyl alcohol, unspecified (UNII: 532B59J990)  
    povidone K30 (UNII: U725QWY32X)  
    sodium bicarbonate (UNII: 8MDF5V39QO)  
    talc (UNII: 7SEV7J4R1U)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code VVV;SCC
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34103/15/2013
    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 Hydrochloride25 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    starch, corn (UNII: O8232NY3SJ)  
    croscarmellose sodium (UNII: M28OL1HH48)  
    crospovidone (15 mpa.s at 5%) (UNII: 68401960MK)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    hypromellose, unspecified (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    microcrystalline cellulose (UNII: OP1R32D61U)  
    polydextrose (UNII: VH2XOU12IE)  
    polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
    povidone, unspecified (UNII: FZ989GH94E)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    stearic acid (UNII: 4ELV7Z65AP)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    triacetin (UNII: XHX3C3X673)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 44;544
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 finalpart34104/30/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/25/2014
    Labeler - RB Health (US) LLC (081049410)
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