Label: SEVERE COUGH AND CONGESTION AND COLD AND FLU DAYTIME, NIGHTTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl

  • NDC Code(s): 41250-848-01
  • Packager: Meijer Distribution Inc
  • 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 June 26, 2019

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

  • Active ingredients (in each caplet) (Daytime Severe Congestion & Cough)

    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

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  • Purpose

    Cough suppressant
    Expectorant
    Nasal decongestant

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

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever/fever reducer
    Antihistamine/cough suppressant
    Nasal decongestant

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  • Uses (Daytime only)

    • temporarily relieves:
      • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
      • nasal congestion due to a cold
      • the intensity of coughing
    • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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  • Uses (Nighttime only)

    • temporarily relieves these common cold and flu symptoms:
      • headache
      • sore throat
      • nasal congestion
      • runny nose and sneezing
      • cough
      • minor aches and pains
    • temporarily reduces fever
    • controls cough to help you get to sleep
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  • Warnings (Nighttime only)

    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, consult a doctor promptly.

    Do not use

    • 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.
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
    • if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
    • with any other product containing diphenhydramine, even one used on skin (Nighttime only)

    Ask a doctor before use if you have

    • heart disease
    • diabetes
    • thyroid disease
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland
    • cough that occurs with too much phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis Nighttime only)
    • glaucoma (Nighttime only)
    • liver disease (Nighttime only)

    Ask a doctor or pharmacist before use if you are (Nighttime only)

    • taking the blood thinning drug warfarin
    • taking sedatives or tranquilizer

    When using this product

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

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not get better within 7 days or occur with fever (Daytime only)
    • redness or swelling is present (Nighttime only)
    • pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
    • new symptoms occur (Nighttime only)
    • fever gets worse or lasts more than 3 days (Nighttime only)
    • 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.

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  • 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
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  • 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
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  • Inactive ingredients (Daytime only)

    corn starch, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

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  • Inactives (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

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  • Questions or comments?

    1-800-426-9391

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  • Principal Display Panel

    COMBO PACK
    Total 30 Caplets

    NDC 41250-848-01

    Meijer®

    Compare to Maximum
    Strength Mucinex®
    FAST-MAX® DAY TIME
    Severe Congestion
    & Cough
    active ingredients*

    Daytime
    severe
    cough &
    congestion

    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

    Cough Suppressant
    Expectorant
    Nasal Decongestant

    MAXIMUM STRENGTH

    • Controls Cough,
    • Relieves Nasal & Chest Congestion
    • Thins & Loosens Mucus

    20 Caplets

    Actual Size 

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

    Nighttime

    cold &
    flu

    Acetaminophen 325 mg
    Diphenhydramine HCl 12.5 mg
    Phenylephrine HCl 5 mg

    Pain Reliever/Fever Reducer
    Antihistamine/Cough Suppressant
    Nasal Decongestant

    MAXIMUM STRENGTH

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

    10 Caplets

    Actual Size 

    *This product is not manufactured or distributed by Reckitt
    Benckiser LLC, owner of the registered trademark Maximum
    Strength Mucinex® FAST-MAX® Day Time Severe Congestion &
    Cough and Night Time Cold & Flu.
    50844                 ORG051764869401

    DIST. BY MEIJER
    DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544
    www.meijer.com

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

    Meijer 44-648694

    Meijer 44-648694

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  • INGREDIENTS AND APPEARANCE
    SEVERE COUGH AND CONGESTION AND COLD AND FLU  DAYTIME, NIGHTTIME
    acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-848
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41250-848-01 1 in 1 CARTON; Type 0: Not a Combination Product 07/01/2017
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 BLISTER PACK 20 
    Part 2 1 BLISTER PACK 10 
    Part 1 of 2
    SEVERE COUGH AND CONGESTION  DAYTIME
    dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    Color RED (Maroon) Score no score
    Shape OVAL Size 19mm
    Flavor Imprint Code 44;648
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/20/2015
    Part 2 of 2
    COLD AND FLU  NIGHTTIME
    acetaminophen. diphenhydramine hcl, phenylephrine hcl tablet, film coated
    Product Information
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN (UNII: O8232NY3SJ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (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)  
    Product Characteristics
    Color BLUE Score no score
    Shape OVAL Size 19mm
    Flavor Imprint Code 44;694
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part341 07/01/2017
    Labeler - Meijer Distribution Inc (006959555)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867894 MANUFACTURE(41250-848)
    Establishment
    Name Address ID/FEI Business Operations
    LNK International, Inc. 832867837 PACK(41250-848)
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