Label: LIL DRUG STORE COLD RELIEF- acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 21, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Guaifenesin 200 mgExpectorant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • for the temporary relief of the following cold/flu symptoms:
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • cough
      • impulse to cough
    • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
    • temporarily reduces fever
  • 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.

    Sore throat warning

    If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

    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 2 tablets with water every 6-8 hours as needed
    • do not take more than 8 tablets in 24 hours, or as directed by a doctor
    children under 12 years of age
    • ask 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 or pouch for expiration date and lot number
  • Inactive ingredients

    maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton

    QUALITY

    GUARANTEED

    on
    the
    Go
    PACKS

    Cold

    Cold

    Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

    Non-Drowsy Relief of

    • Cough, Impulse to Cough
    • Nasal Congestion
    • Sore Throat

    SEVERE
    CONGESTION

    6
    Tablets
    3 POUCHES, 2 TABLETS PER POUCH

    Lil'
    DrugStore ®

    PDP

  • PRINCIPAL DISPLAY PANEL - 20 Tablet Carton - 9828

    EZ Paks™

    Stores & Travels Easily!

    Compare to the active ingredients in

    Tylenol ® Cold Head Congestion*

    NON-DROWSY FORMULA

    Cold Relief

    Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

    SEVERE CONGESTION

    Contains 4 Active Medicines:

    Acetaminophen... relieves Headache, Sore Throat

    Dextromethorphan HBr...relieves Coughing

    Guaifenesin...relieves Chest Congestion

    Phenylephrine HCl...relieves Nasal Congestion

    20 TABLETS

    IN 10 POUCHES OF 2 TABLETS

    Lil'

    Drug Store ®

    Principal Display Panel - 20 Tablet Carton - 9828

  • INGREDIENTS AND APPEARANCE
    LIL DRUG STORE COLD RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9728
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code FR12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9728-33 in 1 CARTON07/06/2016
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9728-810 in 1 CARTON02/03/201102/11/2018
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9728-430 in 1 CARTON02/03/201102/11/2018
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/03/2011
    LIL DRUG STORE COLD RELIEF 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9828
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 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)  
    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)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;273
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-9828-33 in 1 CARTON02/03/201106/14/2019
    12 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:66715-9828-810 in 1 CARTON02/03/201102/11/2018
    22 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:66715-9828-430 in 1 CARTON02/03/201102/11/2018
    32 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34102/03/2011
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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