MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU AND MUCINEX NIGHTSHIFT SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit

Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu by

Drug Labeling and Warnings

Maximum Strength Mucinex Fast-Max Cold and Flu and Mucinex NightShift Severe Cold and Flu by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • Inactive ingredients (MUCINEX NIGHTSHIFT SEVERE COLD & FLU)

    ammonium glycyrrhizate, anhydrous citric acid, ascorbic acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavors, glycerin (soy), propylene glycol, sodium benzoate, sorbitol, sucralose, triacetin, triethyl citrate, water, xanthan gum

  • Questions?

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

  • SPL UNCLASSIFIED SECTION

    Dist. by: RB Health (US), Parsippany, NJ 07054-0224

    Made in England

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC: 63824-139-36

    MAXIMUM STRENGTH

    Mucinex®
    FAST-MAX ®

    COLD & FLU

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

    HEADACHE
    BODY PAIN
    SORE THROAT
    FEVER
    CHEST CONGESTION
    COUGH
    NASAL CONGESTION
    SINUS CONGESTION
    SINUS PRESSURE
    ALL IN
    ONE*

    FOR AGES 12+

    MAXIMUM STRENGTH

    Mucinex®
    NIGHTSHIFT

    SEVERE COLD & FLU

    Acetaminophen – Pain Reliever/Fever Reducer
    Dextromethorphan HBr – Cough Suppressant
    Phenylephrine HCl – Nasal Decongestant Triprolidine HCl – Antihistamine

    HEADACHE
    BODY PAIN
    SORE THROAT
    FEVER
    ITCHY THROAT
    COUGH
    NASAL CONGESTION
    SNEEZING
    RUNNY NOSE
    ALL IN
    ONE*

    FOR AGES 12+

    THREE – 6 FL OZ (180 mL) bottles TOTAL – 18 FL OZ (540 mL)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU AND MUCINEX NIGHTSHIFT SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and triprolidine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63824-139
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-139-361 in 1 CARTON05/07/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 180 mL
    Part 22 BOTTLE 360 mL
    Part 1 of 2
    MUCINEX NIGHTSHIFT SEVERE COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and triprolidine hydrochloride solution
    Product Information
    Item Code (Source)NDC: 63824-504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRIACETIN (UNII: XHX3C3X673)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-504-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/2020
    Part 2 of 2
    MAXIMUM STRENGTH MUCINEX FAST-MAX COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
    Product Information
    Item Code (Source)NDC: 63824-548
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 63824-548-66180 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34107/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/05/2021
    Labeler - RB Health (US) LLC (081049410)

  • © 2022 FDA.report
    This site is not affiliated with or endorsed by the FDA.