Label: CAREONE DAY SEVERE COLD NIGHT COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kit

  • NDC Code(s): 41520-997-90
  • Packager: American Sales Company
  • 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 14, 2018

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  • Active ingredients (in each liquid gel) – DAY Severe Cold

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes – DAY Severe Cold

    Pain reliever/fever reducer

    Cough suppressant

    Expectorant

    Nasal decongestant

  • Active ingredients (in each liquid gel) – NIGHT Cold & Flu

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Doxylamine succinate 6.25 mg

    Phenylephrine HCl 5 mg

  • Purposes – NIGHT Cold & Flu

    Pain reliever/fever reducer

    Cough suppressant

    Antihistamine

    Nasal decongestant

  • Uses

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

    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 these products

    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

    •
    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 these products.
    •
    if you have ever had an allergic reaction to these products or any of their ingredients
  • Ask a doctor before use if you have

    •
    liver disease
    •
    heart disease
    •
    diabetes
    •
    high blood pressure
    •
    thyroid disease
    •
    trouble urinating due to an enlarged prostate gland
    •
    glaucoma (NIGHT only)
    •
    a breathing problem such as emphysema or chronic bronchitis (NIGHT only)
    •
    persistent or chronic cough such 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

    •
    taking the blood thinning drug warfarin
    •
    taking sedatives or tranquilizers (NIGHT only)
  • When using these products

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

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 10 liquid gels in any 24-hour period
    •
    adults and children 12 years of age and older: take 2 liquid gels every 4 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients (DAY only)

    edible ink*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

  • Inactive ingredients (NIGHT only)

    D&C yellow #10, edible ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    COMBINATION PACK

    Compare to the active ingredients in Mucinex® Fast-Max® Day Severe Cold

    DAY SEVERE COLD

    Pain Reliever/Fever Reducer – Acetaminophen

    Cough Suppressant – Dextromethorphan HBr

    Expectorant – Guaifenesin

    Nasal Decongestant – Phenylephrine HCl

    Maximum Strength

    Relieves Aches, Fever & Sore Throat

    Controls Cough

    Relieves Nasal & Chest Congestion

    Thins & Loosens Mucus

    Fast Dissolving Liquid Gels

    For Ages 12+

    Gluten Free

    Actual Size

    OUR PHARMACISTS RECOMMEND

    16

    LIQUID GELS

    (Liquid Filled Capsules)

    Compare to the active ingredients in Mucinex® Fast-Max® Night Cold & Flu

    NIGHT COLD & FLU

    Pain Reliever/Fever Reducer – Acetaminophen

    Cough Suppressant – Dextromethorphan HBr

    Antihistamine – Doxylamine Succinate

    Nasal Decongestant – Phenylephrine HCl

    Maximum Strength

    Relieves Aches, Fever & Sore Throat

    Controls Cough

    Relieves Nasal Congestion

    Relieves Runny Nose & Sneezing

    Fast Dissolving Liquid Gels

    For Ages 12+

    Gluten Free

    Actual Size

    OUR PHARMACISTS RECOMMEND

    8

    LIQUID GELS

    (Liquid Filled Capsules)

    Day Severe Cold Night Cold & Flu Carton Image 1
    Day Severe Cold Night Cold & Flu Carton Image 2
  • INGREDIENTS AND APPEARANCE
    CAREONE DAY SEVERE COLD NIGHT COLD AND FLU 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, doxylamine succinate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-997
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-997-901 in 1 KIT; Type 0: Not a Combination Product08/25/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 18 BLISTER PACK 16 
    Part 24 BLISTER PACK 8 
    Part 1 of 2
    CAREONE DAY SEVERE COLD 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl capsule, liquid filled
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeCAPSULESize25mm
    FlavorImprint Code 7G0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    18 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart341
    Part 2 of 2
    CAREONE NIGHT COLD AND FLU 
    acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
    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 (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeCAPSULESize20mm
    FlavorImprint Code 345
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 CARTON
    12 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2017
    Labeler - American Sales Company (809183973)
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