WALGREEN DAY TIME NIGHTTIME COLD AND FLU RELIEF HONEY FLAVOR- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin 
WALGREENS 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.

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Walgreen DayTime NightTime Cold & Flu Relief Drug Facts

Active ingredients (in each 15 mL) – NightTime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion and pressure
minor aches and pains
headache
fever
sore throat
runny nose and sneezing
cough due to minor throat and bronchial irritation
cough to help you sleep
reduces swelling of nasal passages
promotes nasal and/or sinus drainage
temporarily restores freer breathing through the nose

Warnings

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

more than 4 doses in 24 hours, which is the maximum daily amount for this product
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.
to make child sleepy

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin.

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15mL every 4 hrs

children under 4 to under 6 yrs

do not use unless directed by a doctor

Children under 4 yrs

Do not use

Other information

each 15 mL contains: sodium 9 mg
store at room temperature
Do not refrigerate

Inactive ingredients

citric acid, D&C yellow #10, edetate disodium, FD&C Green No 3, FD&C Red No.40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions or comments?

1-866-467-2748

Active ingredients (in each 15 mL) - Day Time

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion
sinus congestion and pressure
cough due to minor throat and bronchial irritation
minor aches and pains
headache
fever
sore throat
reduces swelling of nasal passages
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

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

more than 4 doses in 24 hours, which is the maximum daily amount for this product.
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.

When using this product

do not use more than directed

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as directed
only use the dose cup provided
do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15mL every 4 hrs

children under 4 to under 6 yrs

ask a doctor

Children under 4 yrs

do not use

Other information

each 15 mL contains: sodium 9 mg
store at room temperature.
Do not refrigerate.

Inactive ingredients

citric acid, D&C yellow #10, edetate disodium,

FD&C Green #3, FD&C Red No. 40, flavors, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Package/Label Principal Display Panel

VALUE PACK

*Compare to the active ingredients in Vicks® Dayquil™ Severe cold & Flu Honey Flavor

DayTime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Guaifenesin - Expectorant

Phenylephrine HCl - Nasal decongestant

Dextromethorphan HBr - Cough supressant

Headache, Fever, sore Throat, Minor Aches & Pains
Chest Congestion Thins & Loosen Mucus
Nasal Congestion & Sinus Pressure
Cough

Honey Flavor

Naturally and Artificially Flavored

TWO BOTTLES, 12 FL OZ (354 mL)

**Compare to the active ingredients in Vicks® Nyquil™ Severe cold & Flu Honey Flavor

Nighttime

Cold & Flu

Relief

Acetaminophen - Pain reliever / Fever reducer

Phenylephrine HCl - Nasal decongestant

Doxylamine succinate - Antihistamine

Dextromethorphan HBr - Cough supressant

For Relief of

Headache, Fever, Sore Throat, Minor Aches & Pains,
Nasal Congestion & Sinus Pressure
Sneezing, Runny Nose
Cough

Honey Flavor

Naturally and Artificially Flavored

Each; TOTAL 24 FL OZ (708 mL)

Day Time Cold & Flu Nitetime Cold & Flu Relief Honey FlavorValue Pack
WALGREEN DAY TIME NIGHTTIME COLD AND FLU RELIEF  HONEY FLAVOR
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride,guaifenesin kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6120
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6120-241 in 1 PACKAGE; Type 0: Not a Combination Product02/22/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 354 mL
Part 21 BOTTLE 354 mL
Part 1 of 2
WALGREEN NIGHTTIME COLD AND FLU RELIEF  HONEY FLAVOR
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution
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
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1354 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/22/2021
Part 2 of 2
WALGREEN DAYTIME COLD AND FLU RELIEF  HONEY FLAVOR
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 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)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorHONEYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1354 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/22/2021
Labeler - WALGREENS CO. (008965063)

Revised: 3/2021
Document Id: 2bff414d-543f-4f46-ba84-1da1e64b9239
Set id: 2bff414d-543f-4f46-ba84-1da1e64b9239
Version: 1
Effective Time: 20210304
 
WALGREENS CO.