Label: SEVERE COLD, COLD AND FLU MAXIMUM STRENGTH, DAYTIME, NIGHTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit

  • Category: HUMAN OTC DRUG LABEL

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 October 2, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredients (in each caplet) (Daytime Severe Cold)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Active ingredients (in each caplet) (Nighttime Cold & Flu)

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Pain reliever/fever reducer
    Antihistamine/cough suppressant
    Nasal decongestant

  • Uses

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

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

    • with other drugs containing acetaminophen
    • more than 4,000 mg of acetaminophen in 24 hours
    • 3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    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, consulta 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.
    • 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.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • with any other product containing diphenhydramine, even one used on skin (Nighttime only)

    Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • diabetes
    • liver disease
    • high blood pressure
    • 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 occurs with too much phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
    • glaucoma (Nighttime only)

    Ask a doctor or pharmacist before use if you are

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

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children (Nighttime only)
    • marked drowsiness may occur (Nighttime only)
    • avoid alcoholic beverages (Nighttime only)
    • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
    • be careful when driving a motor vehicle or operating machinery (Nighttime 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.

    In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

     If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

  • Directions

    • do not use more than directed
    • do not take more than 12 caplets in any 24-hour period
    • adults and children 12 years and over: take 2 caplets every 4 hours
    • children under 12 years: do not use
  • Other information

    • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients (Daytime only)

    corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

  • Inactive ingredients (Nighttime only)

    corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-426-9391

  • Principal display panel

    CVS Health

    Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX® DAY TIME Severe Cold & NIGHT TIME Cold & Flu*

    NDC 69842-694-01

     MAXIMUM STRENGTH

    Daytime

    Severe Cold

    ACETAMINOPHEN
    Pain reliever, Fever reducer
    DEXTROMETHORPHAN HBr
    Cough suppressant
    GUAIFENESIN - Expectorant
    PHENYLEPHRINE HCl
    Nasal decongestant

    Multi-Symptom

    • Relieves aches, fever
      & sore throat

    • Relieves nasal &
      chest congestion

    • Controls cough

    • Thins & loosens mucus

    For Ages 
    12 & Over

    Actual Size

    MAXIMUM STRENGTH

    Nighttime

    Cold & Flu

    ACETAMINOPHEN
    Pain reliever, Fever reducer
    DIPHENHYDRAMINE HCl
    Antihistamine,
    Cough suppressant
    PHENYLEPHRINE HCl
    Nasal decongestant

    Multi-Symptom

    • Relieves aches, fever

    • Controls cough

    • Relieves nasal
      congestion

    •Relieves runny
      nose & sneezing

    For Ages 
    12 & Over

    Actual Size

    20 DAYTIME CAPLETS & 10 NIGHTTIME CAPLETS
    TOTAL 30 CAPLETS

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
    OPENED OR IF BLISTER UNIT IS TORN, BROKEN
    OR SHOWS ANY SIGNS OF TAMPERING

    *This product is not manufactured or distributed by Reckitt
    Benckiser LLC, owner of the registered trademark Maximum
    Strength Mucinex® FAST-MAX® DAY TIME Severe Cold &
    NIGHT TIME Cold & Flu.

    50844 ORG051761769401

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895
    © 2017 CVS/pharmacy
    CVS.com® 1-800-SHOP CVS V-19849

    CVS Quality
    Money Back Guarantee

    CVS Health 44-617694

    CVS Health 44-617694

     

  • INGREDIENTS AND APPEARANCE
    SEVERE COLD, COLD AND FLU  MAXIMUM STRENGTH, DAYTIME, NIGHTIME
    acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-694
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-694-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product07/01/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 10 
    Part 21 BLISTER PACK 10 
    Part 1 of 2
    SEVERE COLD  MAXIMUM STRENGTH, DAYTIME
    acetaminophen, dextromethorphan hbr, guaifenesin phenylephrine hcl tablet, film 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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorREDScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;617
    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 FINALpart34104/07/2013
    Part 2 of 2
    COLD AND FLU  MAXIMUM STRENGTH, NIGHTTIME
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film 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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code 44;694
    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 FINALpart34107/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34107/01/2017
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867894MANUFACTURE(69842-694)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.038154464PACK(69842-694)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.832867837PACK(69842-694)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.868734088PACK(69842-694)
    Establishment
    NameAddressID/FEIBusiness Operations
    LNK International, Inc.967626305PACK(69842-694)