COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,

  • Home
  • COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,

COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED COLD AND FLU DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,
PDF | XML
NDC 66715-6831-0, 66715-6851-0, 66715-6852-0, 66715-6853-0, 66715-6951-0
Set ID b9cf59e7-e298-46a2-a3a0-abf23f8678f3
Category HUMAN OTC DRUG LABEL
Packager Lil' Drug Store Products, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 10 mgCough suppressant
    Phenylephrine HCl 5 mgNasal decongestant
  • Uses

    • temporarily relieves common cold and flu symptoms
      • minor aches and pains
      • headache
      • sore throat
      • nasal congestion
      • fever
      • cough due to minor throat and bronchial irritation
  • 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.

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

    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, cough, or nasal congestion gets worse or lasts more than 7 days
    • nervousness, dizziness, or sleeplessness occur
    • 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.

    Overdose warning

    Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see Overdose warning)
    • do not take more than 4 doses in 24 hours
    • adults and children 12 years and over: take 2 softgels with water every 4 hours
    • swallow whole; do not crush, chew, or dissolve
    • children under 12 years: do not use
    • when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
  • Other information

    • store between 15°-30°C (59°-86°F)
    • avoid excessive heat
  • Inactive ingredients

    butylated hydroxyanisole1, butylated hydroxytoluene1, FD&C red #401, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide1, white ink

    1
    contains one or more of these ingredients
  • Questions or comments?

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

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Lil' Drug Store Products, Inc.
    9300 Earhart Lane SW
    Cedar Rapids, IA 52404

  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6831

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active Ingredients in
    Vicks® DayQuil® LiquiCaps®**

    Non-drowsy

    Cold & Flu
    Daytime

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

    Relieves

    • Aches • Fever
    • Sore Throat • Cough
    • Nasal Congestion

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - NDC 66715-6831
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6851

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active Ingredients in
    Vicks® DayQuil® LiquiCaps®**

    Non-drowsy

    Cold & Flu
    Daytime

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

    Relieves

    • Aches • Fever
    • Sore Throat • Cough
    • Nasal Congestion

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - NDC 66715-6851
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6951

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active Ingredients in
    Vicks® DayQuil® LiquiCaps®**

    Non-drowsy

    Cold & Flu
    Daytime

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

    Relieves

    • Aches • Fever
    • Sore Throat • Cough
    • Nasal Congestion

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - NDC 66715-6951
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6852

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active Ingredients in
    Vicks® DayQuil® LiquiCaps®**

    Cold & Flu
    Daytime

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

    Relieves
    • Aches • Fever
    • Sore Throat • Cough
    • Nasal Congestion

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - NDC 66715-6852
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - NDC 66715-6853

    QUALITY
    ⋆ GUARANTEED ⋆

    Compare to the Active Ingredients in
    Vicks® DayQuil® LiquiCaps®**

    Cold & Flu
    Daytime

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

    Relieves
    • Aches • Fever
    • Sore Throat • Cough
    • Nasal Congestion

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - NDC 66715-6853
  • INGREDIENTS AND APPEARANCE
    COLD AND FLU DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6831
    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 Hydrobromide10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    FD&C yellow No. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitan (UNII: 6O92ICV9RU)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 95A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6831-06 in 1 CARTON10/01/201502/21/2023
    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 FINALpart34109/05/201402/21/2023
    COLD AND FLU DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6851
    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 Hydrobromide10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    FD&C yellow No. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitan (UNII: 6O92ICV9RU)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code P19
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6851-06 in 1 CARTON10/01/201502/21/2023
    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 FINALpart34109/05/201402/21/2023
    COLD AND FLU DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6951
    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 Hydrobromide10 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Sorbitan (UNII: 6O92ICV9RU)  
    Sorbitol (UNII: 506T60A25R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code AS016
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6951-06 in 1 CARTON01/28/201902/21/2023
    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 finalpart34109/05/201402/21/2023
    COLD AND FLU DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6852
    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 Hydrobromide10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    FD&C yellow No. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitan (UNII: 6O92ICV9RU)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 512
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6852-06 in 1 CARTON10/01/201501/28/2022
    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 FINALpart34109/05/201401/28/2022
    COLD AND FLU DAYTIME 
    acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6853
    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 Hydrobromide10 mg
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
    Inactive Ingredients
    Ingredient NameStrength
    Butylated Hydroxyanisole (UNII: REK4960K2U)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    FD&C red No. 40 (UNII: WZB9127XOA)  
    FD&C yellow No. 6 (UNII: H77VEI93A8)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sorbitan (UNII: 6O92ICV9RU)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code P119
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6853-06 in 1 CARTON10/01/201501/28/2022
    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 FINALpart34109/05/201401/28/2022
    Labeler - Lil' Drug Store Products, Inc (093103646)
View All Sections

Related Drugs

Search DailyMed Drugs