Label: DAYTIME SINUS SEVERE- acetaminophen, guaifenesin, phenylephrine hcl tablet, film-coated tablet, film coated

  • NDC Code(s): 66715-6744-9
  • Packager: Lil' Drug Store Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Drug Facts

  • Active ingredients

    Active ingredients

    Acetaminophen 325 mg
    Guaifenesin 200 mg
    Phenylephrine HCl 5 mg

  • Purpose

    Purpose
    Pain reliever/fever reducer
    Expectorant
    Nasal decongestant

  • Uses

    Uses

    • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • headache
    • nasal congestion
    • minor aches and pains
    • sinus congestion and pressure
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever
  • Warnings

    Liver warning

    Liver warning: This product contains 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

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • blisters
    • rash
    • skin reddening

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    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 this product.
    • if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor ...

    Ask a doctor before use if you have

    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
    • heart disease
    • thyroid disease
    • diabetes
    • liver disease
    • high blood pressure
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist ...

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

    When using this product do not exceed recommended dosage.

    Stop use

    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. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    Directions

    • do not take more than directed
    • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
    • children under 12 years: ask a doctor
  • Other information

    Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
  • Inactive ingredients

    Inactive ingredients corn starch, crospovidone, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

  • Questions or comments?

    Questions or comments? 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

  • PDP/Package

    [caduceus]

    *Compare to the Active Ingredients
    in Tylenol® SINUS SEVERE

    Daytime

    Sinus

    Severe

    Acetaminophen, Guaifenesin, Phenylephrine HCI
    Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant

    Non-Drowsy Relief of
    • Sinus Headache
    • Sinus Pressure
    • Nasal Congestion
    • Mucus & Chest Congestion

    [caplet image]

    Actual Size

    24

    Caplets

    [Lil' Drug Store logo]

    PDP/Package

  • INGREDIENTS AND APPEARANCE
    DAYTIME SINUS SEVERE 
    acetaminophen, guaifenesin, phenylephrine hcl tablet, film-coated tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6744
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize19mm
    FlavorMINTImprint Code 44;527
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6744-912 in 1 CARTON08/02/2022
    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 DrugM01208/02/2022
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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