DAYTIME NIGHTTIME COLD AND FLU- acetaminophen dextromethorphan hbr phenylephrine hci doxylaminesucinate 
The Kroger Co.

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.

----------

Drug Facts

Active ingredients  (in each 15 mL) DAYTIME

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for (in each 30 mL) NIGHTTIME

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Purposes for Day Time

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

DAYTIME

NIGHTTIME

Warnings

DAYTIME

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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.

NIGHTTIME

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

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

DAYTIME NIGHTTIME

  • 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 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if you have

DAYTIME

  • liver disease
  • heart disease 
  • high blood pressure
  • thyroid disease
  • diabetes
  • a sodium-restricted diet
  • 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)

NIGHTTIME

  • 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

DAYTIME

taking the blood thinning drug warfarin.

NIGHTTIME

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

When using this product

DAYTIME

do not exceed recommended dosage.

NIGHTTIME

  • 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 and tranquilizers may increase drowsiness

Stop use and ask a doctor if

DAYTIME

  • nervousness, dizziness or sleeplessness occur
  • pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult)
  • 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.

NIGHTTIME

  • 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,

DAYTIME NIGHTTIME

ask a health professional before use.

Keep out of reach of children.

DAYTIME NIGHTTIME

Taking more than the recommended dose (overdose) may couse liver damage. In case of overdose, get medical help or contact a Poison Control Center(1-800-222-1222) 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

DAYTIME

adults and children 12 years and over30 mL every 4 hours 
children 6 to under 12 years 15 mL every 4 hours 
children 4 to under 6 yearsask a doctor 
children under 4 years do not use 


NIGHTTIME

Other information

DAYTIME

NIGHTTIME

Inactive ingredients

Day Time 

citric acid, FD&C yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride,sodium citrate, sorbitol, sucralose, xantham gum

Night Time 

acesulfame potassium, alcohol, anhydrous citric acid, D&C yellow #10, FD&C green #3, FD&C yellow #6 flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium trisodium citrate dihydrate

Questions or comments?

Call 1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of VICKS® DAYQUIL®& VICKS® NYQUIL® COLD & FLU *See side panel

Cold & Flu

DayTime

Multi-Symptom Relief

Acetaminophen

Dextromethorphan HBr

Phenylephrine HCI

Pain Reliever

Fever Reducer

Cough Suppressant

Nasal Decongestant

For Ages 6 Years & Older

Antihistamine Free

Alcohol Free

Cold & Flu

NightTime

Multi-Symptom Relief

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Pain Reliever

Fever Reducer

Cough Suppressant

Antihistamine

For ages 12 Years & Older

ALCOHOL 10%

FL OZ (mL)

when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

*Vicks®, DayQuil® and NyQuil® are registered trademarks of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Company is not affiliated with The Kroger Co. or these product

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

DIST. BT THE KROGER CO.

CINCINNATI, OHIO 45202

www.kroger.com

Product Label

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg, Acetaminophen 650 mg, Dextromethorphan HBr 30 mg, Doxylamine Succinate 12.5 mg

KROGER Daytime Nighttime Cold & Flu Relief

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen dextromethorphan hbr phenylephrine hci doxylaminesucinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-667
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-667-241 in 1 KIT; Type 0: Not a Combination Product10/30/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 355 mL
Part 21 BOTTLE 355 mL
Part 1 of 2
DAYTIME COLD AND FLU 
acetaminophen dextromethorphan hbr phenylephrine hci liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/30/2020
Part 2 of 2
NIGHTTIME COLD AND FLU 
acetaminophen dextromethorphan hbr doxylamine succinate liquid
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE12.5 mg  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ALCOHOL (UNII: 3K9958V90M)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1355 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34110/30/2020
Labeler - The Kroger Co. (006999528)

Revised: 11/2020
Document Id: 725490d8-e8b2-4aa7-a422-072ded904958
Set id: a6212f05-96b6-4ad8-9e30-a738d8419ad1
Version: 1
Effective Time: 20201111
 
The Kroger Co.