Label: CAREONE SINUS RELIEF DAY TIME SINUS RELIEF NIGHT TIME- acetaminophen, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride kit

  • NDC Code(s): 41520-806-80
  • 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 5, 2019

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  • Active ingredients (in each caplet) SINUS RELIEF Day

    Acetaminophen 325 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever

    Expectorant

    Nasal decongestant

  • Active ingredients (in each caplet) SINUS RELIEF Night

    Acetaminophen 325 mg

    Diphenhydramine HCl 12.5 mg

    Phenylephrine HCl 5 mg

  • Purposes

    Pain reliever

    Antihistamine/cough suppressant

    Nasal decongestant

  • Uses

    •
    temporarily relieves:
    •
    nasal congestion
    •
    headache
    •
    minor aches and pains
    •
    sinus congestion and pressure
    •
    runny nose and sneezing (NIGHT only)
    •
    cough (NIGHT only)
    •
    temporarily promotes nasal and/or sinus drainage
    •
    helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (DAY only)
  • 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.

    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.
    •
    with any other product containing diphenhydramine, even one used on skin (NIGHT only)
    •
    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 caplets in any 24-hour period
    •
    adults and children 12 years of age and older: take 2 caplets every 4 hours
    •
    children under 12 years of age: do not use
  • Other information

    •
    each caplet contains: sodium 4 mg (DAY only)
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients (DAY only)

    croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Inactive ingredients (NIGHT only)

    crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    COMBINATION PACK

    Compare to the active ingredients in Mucinex® Sinus-Max® Day

    SINUS RELIEF DAY TIME

    Pain Reliever – Acetaminophen

    Expectorant – Guaifenesin

    Nasal Decongestant – Phenylephrine HCl

    Maximum Strength

    Relieves Sinus Pressure, Headache & Congestion

    Thins & Loosens Mucus

    Actual Size

    For Ages 12+

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    10 CAPLETS

    Compare to the active ingredients in Mucinex® Sinus-Max® Night

    SINUS RELIEF NIGHT TIME

    Pain Reliever – Acetaminophen

    Antihistamine/Cough Suppressant – Diphenhydramine HCl

    Nasal Decongestant – Phenylephrine HCl

    Maximum Strength

    Relieves Nasal Congestion, Sinus Pressure & Pain

    Relieves Runny Nose, Sneezing & Cough

    Actual Size

    For Ages 12+

    Gluten Free

    OUR PHARMACISTS RECOMMEND

    10 CAPLETS

    sinus relief day time sinus relief night time image 1
    sinus relief day time sinus relief night time image 2
  • INGREDIENTS AND APPEARANCE
    CAREONE SINUS RELIEF DAY TIME SINUS RELIEF NIGHT TIME 
    acetaminophen, guaifenesin, phenylephrine hydrochloride, diphenhydramine hydrochloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-806
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-806-801 in 1 KIT; Type 0: Not a Combination Product10/08/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 BLISTER PACK 10 
    Part 25 BLISTER PACK 10 
    Part 1 of 2
    CAREONE SINUS RELIEF DAY TIME 
    acetaminophen, guaifenesin, phenylephrine hydrochloride tablet, film coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code L145
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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 SINUS RELIEF NIGHT TIME 
    acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride, 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
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    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)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize16mm
    FlavorImprint Code L27H
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/08/2019
    Labeler - American Sales Company (809183973)
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