Label: MUCINAR PLUS- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin 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 February 25, 2019

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

  • Active ingredients in Daytime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Active ingredients in Nighttime (in each softgel)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCI 5 mg

  • Purpose for Daytime

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Purpose for Nighttime

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

    DAYTIME

    • temporarily relieves these common cold and flu symptoms
      • headache
      • nasal congestion
      • sore throat
      • cough
      • minor aches and pains
      • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
      • temporarily reduces fever

    NIGHTTIME

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

    DAYTIME and NIGHTTIME

    Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

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

    DAYTIME and NIGHTTIME

    • 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.

    Ask a doctor before use if you have

    DAYTIME

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

    NIGHTTIME

    • liver disease
    • diabetes
    • high blood pressure
    • heart disease
    • glaucoma
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or chronic cough that lasts or 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

    DAYTIME

    taking the blood thinning drug warfarin

    NIGHTTIME

    taking the blood thinning drug warfarin

    taking sedatives or tranquilizers

    When using this product,

    DAYTIME

    do not use more than directed

    NIGHTTIME

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

    Stop use and ask a doctor if

    DAYTIME and NIGHTTIME

    • nervousness, dizziness, or sleeplessness
    • 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 coukld be signs of a serious condition.

    If pregnant or breast-feeding,

    DAYTIME and NIGHTTIME

    ask a health professional before use.

    Keep out of reach of children.

    DAYTIME and NIGHTTIME

    Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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

    DAYTIME

    • do not take more than directed (see Overdose warning)
    • do not take more than 12 softgels (Daytime and NightTime) in any 24-hour period
    • adults and children 12 years of age and older: take 2 softgels every 4 hours
    • children under 12 years of age: do not use
    • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

    NIGHTTIME

    • do not take more than directed (see Overdose warning)
    • do not take more than 12 softgels (Daytime and Nighttime) in any 24-hour period
    • adults and children 12 years of age and older: take 2 softgels every 4 hours
    • children under 12 years of age: do not use
    • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing 
  • Other information

    DAYTIME and NIGHTTIME

    • swallow whole; do not crush, chew, or dissolve
    • store between 15-30ºC (59-86F)
    • avoid excessive heat
  • Inactive ingredients

    DAYTIME

    FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

    NIGHTTIME

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitan*, sorbitol, titanium dioxide

  • Principal Display Panel

    DAYTIME

    DAYTIME • MAXIMUM STRENGTH

    Mucus Relief

    Severe Cold

    Acetaminophen / Pain Reliever / Fever Reducer

    Dextromethorphan HBr / Cough Suppressant

    Guaifenesin / Expectorant

    Phenylephrine HCI / Nasal Decongestant

    • Relieves aches, fever & sore throat
    • Controls cough
    • thins & loosens mucus
    • Clears nasal & chest congestion
    • For ages 12 years & over
    • Alcohol-free

    SOFTGELS*

    (*Liqui-Filled Capsules)

    NIGHTTIME

    NIGHTTIME • MAXIMUM STRENGTH

    Cold & Flu

    Acetaminophen / Pain Reliever / Fever Reducer

    Dextromethorphan HBr/ Cough Suppressant

    Doxylamine Succinate / Antihistamine

    Phenylephrine HCI / Nasal Decongestant

    • Relieves aches, fever & sore throat
    • Controls cough
    • Relieves runny nose & sneezing
    • Relieves nasal congestion
    • For ages 12 years & over
    • Alcohol-free
  • Product Label

    Acetaminophen HBr 10 mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg, Guaifenesin 200mg

    Mucinar PLUS

  • INGREDIENTS AND APPEARANCE
    MUCINAR PLUS 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl,guaifenesin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72828-520
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72828-520-241 in 1 CARTON; Type 0: Not a Combination Product02/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK
    Part 216 BLISTER PACK 16 
    Part 1 of 2
    NIGHTTIME COLD AND FLU  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci capsule
    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
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    SHELLAC (UNII: 46N107B71O)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 116
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2019
    Part 2 of 2
    DAYTIME MUCUS RELIEF SEVERE COLD  MAXIMUM STRENGTH
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci capsule
    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
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 341
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    116 in 1 CARTON
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34102/01/2019
    Labeler - Plus Distributors LLC (116922831)