COLD AND FLU DAYTIME NIGHTTIME SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl 
Walgreen Company

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Walgreens 44-042078

Active ingredients (in each 20 mL) (Daytime Cold & Flu)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg 

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each 20 mL) (Nighttime Severe Cold & Flu)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Triprolidine HCl 2.5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine

Uses

Warnings

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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • liver disease
  • diabetes
  • thyroid disease
  • heart disease
  • glaucoma (Nighttime only)
  • difficulty in urination due to enlargement of the prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • high blood pressure

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion, or cough gets worse or lasts more than 7 days
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • 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.

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

Do not take DAYTIME and NIGHTTIME products at the same time.

Directions (Daytime only)

Directions (Nighttime only)

Other information

Inactive ingredients (Daytime only)

anhydrous citric acid, disodium edetate, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum

Inactive ingredients (Nighttime only)

anhydrous citric acid, FD&C blue #1, FD&C red #40, FD&C yellow #6, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

Questions?

Call 1-800-910-6874

Principal display panel

DAY & NIGHT PACK
NDC 0363-4278-45

Walgreens
• WALGREENS •
PHARMACIST RECOMMENDED†
Compare to the active ingredients in Maximum
Strength Mucinex® FAST-MAX® Cold & Flu
& NIGHTSHIFT® Severe Cold & Flu††



DAYTIME
Cold & Flu


ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT

 

Maximum Strength

• Relieves headache, body pain,
  sore throat, fever, chest congestion,
  cough, nasal congestion,
  sinus congestion & pressure
• 12 years & older

 

 

 

 

 

NIGHTTIME
Severe
Cold & Flu

ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
TRIPROLIDINE HCl / ANTIHISTAMINE

Maximum Strength

• Relieves headache, body pain,
   sore throat, fever, itchy throat, cough,
   nasal congestion, runny nose & sneezing
• 12 years & older

2 – 6 FL OZ (177 mL) BOTTLES / TOTAL 12 FL OZ (355 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
Do not take Daytime Cold & Flu and Nighttime
Severe Cold & Flu at the same time.

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2023 Walgreen Co.

†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by RB Health (US) LLC, owner
of the registered trademarks Maximum Strength Mucinex® FAST-MAX® Cold &
Flu and NIGHTSHIFT® Severe Cold & Flu.

44-042078

Walgreens 44-042078


COLD AND FLU  DAYTIME NIGHTTIME SEVERE
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, triprolidine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4278
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-4278-451 in 1 PACKAGE; Type 0: Not a Combination Product10/21/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 177 mL
Part 21 BOTTLE, PLASTIC 177 mL
Part 1 of 2
COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
Product Information
Item Code (Source)NDC:0363-9042
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBERRY (MIXED) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9042-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/21/2023
Part 2 of 2
COLD AND FLU  SEVERE
acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl solution
Product Information
Item Code (Source)NDC:0363-8078
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 20 mL
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE2.5 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorFRUIT (MIXED) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-8078-45177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01210/21/2023
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305manufacture(0363-4278) , pack(0363-4278)

Revised: 10/2023
Document Id: d68c44f8-2ac5-49f0-9051-2535279a140c
Set id: afbe932c-c26a-4fac-9ea3-d050db01eded
Version: 1
Effective Time: 20231021
 
Walgreen Company