Label: SINUS RELIEF- acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl 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 November 4, 2020

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  • Active ingredients (in each caplet) – SINUS RELIEF Day

    Acetaminophen 325 mg

    Guaifenesin 200 mg

    Phenylephrine HCl 5 mg

  • Active ingredients (in each caplet) – SINUS RELIEF Night

    Acetaminophen 325 mg

    Diphenhydramine HCl 25 mg

    Phenylephrine HCl 5 mg

  • Purpose – SINUS RELIEF Day

    Pain reliever

    Expectorant

    Nasal decongestant

  • Purpose – SINUS RELIEF Night

    Pain reliever

    Antihistamine

    Nasal decongestant

  • Uses

    •
    temporarily relieves:
    •
    nasal congestion
    •
    headache
    •
    minor aches and pains
    •
    sinus congestion and pressure
    •
    runny nose and sneezing (SINUS RELIEF 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 (SINUS RELIEF 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 (SINUS RELIEF 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 (SINUS RELIEF Night only)
    •
    a breathing problem such as emphysema or chronic bronchitis (SINUS RELIEF Night only)
    •
    persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (SINUS RELIEF Day only)
    •
    cough that occurs with too much phlegm (mucus) (SINUS RELIEF Day only)
  • Ask a doctor or pharmacist before use if you are

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

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

    •
    nervousness, dizziness, or sleeplessness occur
    •
    pain, cough or nasal congestion 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 persistent headache. These could be signs of a serious condition. (SINUS RELIEF Day only)
  • 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 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 (SINUS RELIEF Day only)
    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients (SINUS RELIEF 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 (SINUS RELIEF Night only)

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

  • Questions or comments?

    1-800-632-6900

  • Package/Label Principal Display Panel – SINUS RELIEF Day

    COMPARE TO the active ingredients of MUCINEX® SINUS-MAX®

    See side panel

    FOR AGES 12+

    MAXIMUM STRENGTH

    Sinus Relief

    Acetaminophen, Pain Reliever

    Guaifenesin, Expectorant

    Phenylephrine HCl, Nasal Decongestant

    Day Time

    Relieves Sinus Pressure, Headache & Congestion

    Thins & Loosens Mucus

    actual size

    10 CAPLETS

    SEE NEW WARNINGS

  • Package/Label Principal Display Panel – SINUS RELIEF Night

    COMPARE TO the active ingredients of MUCINEX® SINUS-MAX®

    See side panel

    FOR AGES 12+

    MAXIMUM STRENGTH

    Sinus Relief

    Acetaminophen, Pain Reliever

    Diphenhydramine HCl, Antihistamine

    Phenylephrine HCl, Nasal Decongestant

    Night Time

    Relieves Nasal Congestion, Sinus Pressure & Pain

    Relieves Runny Nose & Sneezing

    10 CAPLETS

    actual size

    SEE NEW WARNINGS

    Kroger Sinus Relief Day Time Night Time image 1
    Kroger Sinus Relief Day Time Night Time image 2
  • INGREDIENTS AND APPEARANCE
    SINUS RELIEF 
    acetaminophen, guaifenesin, diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-688
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-688-801 in 1 KIT; Type 0: Not a Combination Product04/10/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 15 BLISTER PACK 10 
    Part 25 BLISTER PACK 10 
    Part 1 of 2
    SINUS RELIEF 
    acetaminophen, guaifenesin, phenylephrine hcl tablet, 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)  
    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
    15 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 finalpart34104/08/2015
    Part 2 of 2
    SINUS RELIEF 
    acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, 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 HYDROCHLORIDE25 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)  
    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 L625
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    15 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34104/10/2015
    Labeler - Kroger Company (006999528)
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