CIRCLE K MULTI-SYMPTOM SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]

CIRCLE K MULTI-SYMPTOM SINUS RELIEF (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]
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NDC 66715-5744-2, 66715-5744-8
Set ID 66170885-fff0-4953-a4ac-02eaad00d594
Category HUMAN OTC DRUG LABEL
Packager Lil' Drug Store Products, Inc.
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Acetaminophen 325 mgPain reliever
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • For the temporary relief of:
      • sinus congestion and pressure
      • nasal congestion
      • headache
      • minor aches and pains
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies
  • Warnings

    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

    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.
    • 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.

    Ask a doctor before use if you have

    • liver disease
    • heart disease
    • diabetes
    • thyroid disease
    • high blood pressure
    • trouble urinating due to an enlarged prostate gland
    • cough that occurs with too much phlegm (mucus)
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema

    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 and ask a doctor if

    • 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 is accompanied by a fever, rash or persistent headache
    • nervousness, dizziness or sleeplessness occur.

    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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    adults and children 12 years and over
    • take 1-2 tablets every 4 hours as needed
    • do not take more than 12 tablets in 24 hours, or as directed by a doctor
    children under 12 years of age
    • consult a doctor
  • Other information

    • store at room temperature 59-86°F (15-30°C)
    • avoid excessive heat and humidity
  • Inactive ingredients

    FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide 1, sodium starch glycolate, starch, stearic acid


    1
    may contain
  • Questions or comments?

    call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

  • SPL UNCLASSIFIED SECTION

    Proudly distributed by Circle K Stores Inc.

  • PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton

    Compare to the Active Ingredients in
    Tylenol® Sinus Severe

    CIRCLE K ®

    Multi-
    Symptom

    Sinus

    severe
    congestion

    Acetaminophen, Guaifenesin and Phenylephrine HCl
    Pain Reliever, Expectorant, Nasal Decongestant

    Non-Drowsy Relief of

    • Chest & Nasal Congestion
    • Sinus Pressure

    ACTUAL SIZE

    4 Tablets
    2 POUCHES, 2 TABLETS PER POUCH

    PRINCIPAL DISPLAY PANEL - 4 Tablet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    CIRCLE K MULTI-SYMPTOM SINUS RELIEF 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-5744
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-5744-22 in 1 CARTON12/30/201811/13/2023
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-5744-88 in 1 CARTON12/30/201804/26/2024
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-5744-33 in 1 CARTON10/15/201904/30/2024
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/07/201504/30/2024
    Labeler - Lil' Drug Store Products, Inc. (093103646)

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