MUCUS RELIEF DAYTIME/NIGHTTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, diphenhydramine hcl 
Walgreen 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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Walgreens 44-617544

Active ingredients (in each caplet)
(Daytime Severe Cold)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Active ingredients (in each caplet)
(Nighttime Cold & Flu)

Acetaminophen 325 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • headache
    • minor aches and pains
    • nasal congestion
    • sore throat
    • cough (Daytime Severe Cold only)
    • runny nose and sneezing (Nighttime Cold & Flu only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime Severe Cold only)
  • temporarily reduces fever

Warnings

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

  • with other drugs containing acetaminophen
  • more than 12 caplets in 24 hours, which is the maximum daily amount
  • 3 or more alcoholic drinks every day while using this product

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
  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin (Nighttime Cold & Flu only)

Ask a doctor before use if you have

  • heart disease
  • liver disease
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime Severe Cold only)
  • cough that occurs with too much phlegm (mucus) (Daytime Severe Cold only)
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime Cold & Flu only)
  • glaucoma (Nighttime Cold & Flu only)

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime Cold & Flu only)
  • marked drowsiness may occur (Nighttime Cold & Flu only)
  • avoid alcoholic drinks (Nighttime Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime Cold & Flu only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime Cold & Flu 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
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache (Daytime Severe Cold only)

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 (overdose) may cause 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

  • do not use more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use

Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients (Daytime Severe Cold)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive ingredients (Nighttime Cold & Flu)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, titanium dioxide, triacetin

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDED‡

NDC 0363-6175-01

DAYTIME
MAXIMUM STRENGTH

Mucus Relief
Severe Cold
Acetaminophen/
Pain Reliever / Fever Reducer
Dextromethorphan HBr/
Cough Suppressant
Guaifenesin / Expectorant
Phenylephrine HCl /
Nasal Decongestant

• Relieves aches, fever &
sore throat
• Controls cough
• Thins & loosens mucus
• Clears nasal & chest congestion

20
CAPLETS Actual Size

NIGHTTIME
MAXIMUM STRENGTH

Mucus Relief
Cold & Flu
Acetaminophen /
Pain Reliever / Fever Reducer,
Diphenhydramine HCl /
Antihistamine
Phenylephrine HCl / 
Nasal Decongestant

• Relieves aches, fever &
sore throat
• Relieves runny nose &
sneezing
•Relieves nasal
congestion

10
CAPLETS Actual Size

Compare to Maximum Strength Mucinex® FAST-MAX® Daytime Severe Cold & Nighttime Cold & Flu active ingredients‡‡

30 TOTAL CAPLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com ©2016 Walgreen Co.

‡Walgreens Pharmacist Survey Study, November 2014.
‡‡This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX® Daytime Severe Cold & Nighttime Cold & Flu.

50844 REV0414B61754401  ORG0714-F_R02
Walgreens 44-617544

Walgreens 44-617544

MUCUS RELIEF  DAYTIME/NIGHTTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, diphenhydramine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6175
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-6175-011 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product04/07/201310/04/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 10 
Part 22 BLISTER PACK 20 
Part 1 of 2
MUCUS RELIEF COLD AND FLU  NIGHTTIME / MAXIMUM STRENGTH
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize16mm
FlavorImprint Code 44;544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/19/2006
Part 2 of 2
MUCUS RELIEF SEVERE COLD  DAYTIME / MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;617
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/07/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/07/201310/04/2021
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(0363-6175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0363-6175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837pack(0363-6175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088pack(0363-6175)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(0363-6175)

Revised: 8/2021
Document Id: 989d3dd3-a202-42f3-b050-caffc1f392f4
Set id: 41f044c5-ad3c-4f31-8944-f7127fdc8240
Version: 8
Effective Time: 20210817
 
Walgreen Company