CAREONE DAY SEVERE COLD NIGHT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE) KIT [AMERICAN SALES COMPANY]

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  • CAREONE DAY SEVERE COLD NIGHT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE) KIT [AMERICAN SALES COMPANY]

CAREONE DAY SEVERE COLD NIGHT COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE) KIT [AMERICAN SALES COMPANY]
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NDC 41520-997-90
Set ID d6a51ac6-ab34-4bca-afea-9373991a71aa
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
Generic Name
Product Class alpha-1 Adrenergic Agonist, Antihistamine
Product Number
Application Number PART341
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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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