COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED LIL DRUG STORE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN H

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  • COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED LIL DRUG STORE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN H

COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED LIL DRUG STORE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN H
PDF | XML
NDC 66715-6734-0, 66715-6834-0, 66715-6847-0, 66715-6848-0, 66715-6849-0
Set ID f2b43b3f-c272-49c7-a601-954e2e4865d6
Category HUMAN OTC DRUG LABEL
Packager Lil' Drug Store Products, Inc.
Generic Name
Product Class Antihistamine
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each softgel)Purposes
    Acetaminophen 325 mgPain reliever/fever reducer
    Dextromethorphan HBr 15 mgCough suppressant
    Doxylamine succinate 6.25 mgAntihistamine
  • Uses

    • temporarily relieves common cold/flu symptoms:
      • sore throat
      • headache
      • minor aches and pains
      • fever
      • runny nose and sneezing
      • 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 daily 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
    • glaucoma
    • trouble urinating due to an enlarged prostate gland
    • a breathing problem or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis 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
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • excitability may occur, especially in children
    • avoid alcoholic drinks
    • marked drowsiness may occur
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • pain 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 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 6 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

    D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide1, white ink

    1
    may contain this ingredient
  • 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 - 66715-6834

    QUALITY
    ⋆ GUARANTEED ⋆

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

    Cold & Flu
    Nighttime

    Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
    Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

    Relieves
    • Sneezing • Runny Nose
    • Cough • Aches
    • Fever • Sore Throat

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - 66715-6834
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6847

    QUALITY
    ⋆ GUARANTEED ⋆

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

    Cold & Flu
    Nighttime

    Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
    Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

    Relieves
    • Sneezing • Runny Nose
    • Cough • Aches
    • Fever • Sore Throat

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - 66715-6847
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6734

    QUALITY
    ⋆ GUARANTEED ⋆

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

    Cold & Flu
    Nighttime

    Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
    Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

    Relieves
    • Sneezing • Runny Nose
    • Cough • Aches
    • Fever • Sore Throat

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - 66715-6734
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6848

    QUALITY
    ⋆ GUARANTEED ⋆

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

    Cold & Flu
    Nighttime

    Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
    Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

    Relieves
    • Sneezing • Runny Nose
    • Cough • Aches
    • Fever • Sore Throat

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - 66715-6848
  • PRINCIPAL DISPLAY PANEL - 12 Softgel Blister Pack Carton - 66715-6849

    QUALITY
    ⋆ GUARANTEED ⋆

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

    Cold & Flu
    Nighttime

    Acetaminophen, Dextromethorphan HBr, and Doxylamine Succinate
    Pain Reliever/Fever Reducer, Cough Suppressant, Antihistamine

    Relieves
    • Sneezing • Runny Nose
    • Cough • Aches
    • Fever • Sore Throat

    ACTUAL SIZE

    12
    Softgels

    Lil'
    Drug Store®

    Principal Display Panel - 12 Softgel Blister Pack Carton - 66715-6849
  • INGREDIENTS AND APPEARANCE
    COLD AND FLU NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6834
    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
    Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 94A
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6834-06 in 1 CARTON01/12/201704/16/2023
    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 finalpart34109/05/201404/16/2023
    LIL DRUG STORE NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6847
    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
    Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code P30
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6847-06 in 1 CARTON01/12/201704/16/2023
    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 finalpart34109/05/201404/16/2023
    COLD AND FLU NIGHTTIME 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6734
    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
    Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code AS017
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6734-06 in 1 CARTON11/15/201804/16/2023
    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 finalpart34109/05/201404/16/2023
    LIL DRUG STORE NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6848
    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
    Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 215
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6848-06 in 1 CARTON01/12/201711/15/2021
    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 finalpart34109/05/201411/15/2021
    LIL DRUG STORE NIGHTTIME COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-6849
    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
    Doxylamine Succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    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)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code P120
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66715-6849-06 in 1 CARTON01/12/201711/15/2021
    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 finalpart34109/05/201411/15/2021
    Labeler - Lil' Drug Store Products, Inc. (093103646)
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