COLD AND FLU NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled 
LIL DRUG STORE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled 
Lil' Drug Store Products, Inc.

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.

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Lil' Drug Store® Nighttime Cold & Flu

Drug Facts

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)

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
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)

Revised: 10/2020
Document Id: 8c2b67bd-6257-4aed-8db2-cfb91ce8c417
Set id: f2b43b3f-c272-49c7-a601-954e2e4865d6
Version: 6
Effective Time: 20201005
 
Lil' Drug Store Products, Inc.