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

  • NDC Code(s): 66715-9744-1, 66715-9744-3, 66715-9744-8, 66715-9844-1, view more
    66715-9844-3, 66715-9844-8
  • 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 December 21, 2021

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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, and 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.

    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
    • consult a doctor
  • Other information

    • do not use if carton or inner pouch is open or torn
    • store at room temperature 59-86°F (15-30°C)
    • avoid excessive heat and humidity
    • see bottom panel of carton or pouch for expiration date and lot number
  • Inactive ingredients

    corn starch 1, croscarmellose sodium 1, FD&C red #40 1, hypromellose 1, maltodextrin 1, microcrystalline cellulose, polyethylene glycol 1, povidone 1, sodium starch glycolate 1, starch 1, stearic acid

    1
    may contain
  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9744

    Compare to the active ingredients in
    Tylenol ® Sinus Congestion & Pain Severe*

    Multi-Symptom
    Sinus Relief
    NON-DROWSY

    Pain Reliever, Nasal Decongestant, Expectorant

    SEVERE CONGESTION

    Contains 3 Active Medicines:
    Acetaminophen...relieves Headache
    Guaifenesin...relieves Chest Congestion
    Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure

    6 TABLETS

    Lil'
    DrugStore ®

    Principal Display Panel - 6 Tablet Pouch Carton - 9744
  • PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9844

    Compare to the active ingredients in
    Tylenol ® Sinus Congestion & Pain Severe*

    Multi-Symptom
    Sinus Relief
    NON-DROWSY

    Pain Reliever, Nasal Decongestant, Expectorant

    SEVERE CONGESTION

    Contains 3 Active Medicines:
    Acetaminophen...relieves Headache
    Guaifenesin...relieves Chest Congestion
    Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure

    6 TABLETS

    Lil'
    DrugStore ®

    Principal Display Panel - 6 Tablet Pouch Carton - 9844
  • INGREDIENTS AND APPEARANCE
    LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9744
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR14
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9744-33 in 1 CARTON06/01/201105/19/2024
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9744-810 in 1 CARTON06/01/201101/09/2018
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9744-130 in 1 CARTON06/01/201101/09/2018
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/201105/19/2024
    LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF 
    acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9844
    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)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;286
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9844-33 in 1 CARTON06/01/201107/13/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9844-810 in 1 CARTON06/01/201101/09/2018
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9844-130 in 1 CARTON06/01/201101/09/2018
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/01/201107/13/2021
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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