COLD AND FLU DAYTIME/NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate 
Kroger Company

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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Cold and Flu Daytime/Nighttime

NightTime COLD & FLU

Drug Facts

Active ingredients (in each Softgel) Purpose
Acetaminophen 325 mgPain reliever / Fever reducer
Dextromethorphan HBr 15 mgCough suppressant
Doxylamine succinate 6.25 mgAntihistamine

Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
  • 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.
  • to make a child sleep

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, & tranquilizers may increase drowsiness

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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over 2 softgels with water every 6 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

Inactive ingredients

FD&C Blue #1, FD&C Yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments

1-800-632-6900

DayTime COLD & FLU

Drug Facts

Active ingredients (in each Softgel) Purpose
Acetaminophen 325 mgPain reliever / Fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
  • 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last 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 directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions

adults & children 12 yrs & over 2 softgels with water every 4 hrs
children 4 to under 12 yrsask a doctor
children under 4 yrsdo not use

Other information

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments

1-800-632-6900

PRINCIPAL DISPLAY PANEL - Kit Carton

*Compare to active ingredients in Vicks® Dayquil™ and Vicks® Nyquil™ Cold & Flu Liquicaps™

NDC 30142-620-48

COLD & FLU

DayTime

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppressant
Nasal Decongestant

Acetaminophen 325mg
Dextromethorphan HBr 10mg
Phenylephrine HCl 5mg

32
SOFTGELS

COLD & FLU

NightTime

Multi-Symptom Relief

Pain Reliever
Fever Reducer
Cough Suppressant
Antihistamine

Acetaminophen 325mg
Dextromethorphan HBr 15mg
Doxylamine succinate 6.25mg

16
SOFTGELS

PRINCIPAL DISPLAY PANEL - Kit Carton
COLD AND FLU DAYTIME/NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-754
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-754-124 in 1 CARTON05/01/2021
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 2
Part 1 of 2
COLD AND FLU DAYTIME 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule, liquid filled
Product Information
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
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)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize20mm
FlavorImprint Code 786
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2021
Part 2 of 2
COLD AND FLU NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule, liquid filled
Product Information
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
Doxylamine Succinate (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) Doxylamine Succinate6.25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C Blue NO. 1 (UNII: H3R47K3TBD)  
D&C Yellow NO. 10 (UNII: 35SW5USQ3G)  
Gelatin, Unspecified (UNII: 2G86QN327L)  
Glycerin (UNII: PDC6A3C0OX)  
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)  
Povidone, Unspecified (UNII: FZ989GH94E)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint Code 787
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/01/2021
Labeler - Kroger Company (006999528)

Revised: 3/2021
Document Id: 16e76239-b9e4-4da5-a0bd-354f0ad38949
Set id: 27d9ccda-8d69-424a-91db-5fe22b230c57
Version: 1
Effective Time: 20210316
 
Kroger Company