Label: LIL DRUG STORE MULTI-SYMPTOM SINUS SEVERE CONGESTION- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

  • NDC Code(s): 66715-6844-8
  • Packager: Lil Drug Store Products, Inc
  • 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 October 5, 2022

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  • 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)

  • PRINCIPAL DISPLAY PANEL - 16 Tablet Pouch Carton

    QUALITY
    GUARANTEED

    Compare to the Active Ingredients
    in Tylenol® Sinus Severe †

    Sinus
    Relief

    on
    the
    Go
    PACKS

    Multi-Symptom
    Sinus

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

    Non-Drowsy Relief of

    • Chest Congestion
    • Nasal Congestion
    • Sinus Pressure

    SEVERE
    CONGESTION

    16
    Tablets
    8 POUCHES, 2 TABLETS PER POUCH

    Lil'
    DrugStore ®

    PRINCIPAL DISPLAY PANEL - 16 Tablet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    LIL DRUG STORE MULTI-SYMPTOM SINUS  SEVERE CONGESTION
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6844
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6844-88 in 1 CARTON03/15/201806/10/2025
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/15/201406/10/2025
    Labeler - Lil Drug Store Products, Inc (093103646)
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