MUCUS DM FAST MAX DAY COLD AND FLU AND NIGHT COLD AND FLU- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl 
WALGREENS

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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726R Walgreens 0363 - 9617 Day Cold & Flu and Night Severe Cold & Flu Tablets

Drug Facts

Active ingredients (in each caplet)
Day Cold & Flu

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


Active ingredients (in each caplet)
Night Severe Cold & Flu
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Triprolidine HCl 1.25 mg


Purposes
Day Cold & Flu

Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Purposes
Night Severe Cold & Flu

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Antihistamine

Uses

Day Cold & Flu

temporarily relieves these common cold and flu symptoms:

temporarily reduces fever
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Night Severe Cold & Flu

temporarily relieves these common cold and flu symptoms:

temporarily reduces fever
controls cough to help you get to sleep

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.

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not use more than directed
  • excitability may occur, especially in children (Night Severe Cold & Flu only)
  • marked drowsiness may occur (Night Severe Cold & Flu only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Night Severe Cold & Flu only)
  • avoid alcoholic drinks (Night Severe Cold & Flu only)
  • use caution when driving a motor vehicle or operating machinery (Night Severe 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
  • cough comes back, or occurs with fever, 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (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

Day Cold & Flu

Night Severe Cold & Flu

Other information

Inactive ingredients Day Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

Inactive ingredients Night Severe Cold & Flu

colloidal silicon dioxide, croscarmellose sodium, mica, microcrystalline cellulose, polyethylene glycol, povidone, stearic acid, talc, titanium dioxide, yellow iron oxide

Questions or Comments?

Call 1-877-290-4008

726R-WG-DYNY-40s-ifc

MUCUS DM FAST MAX DAY COLD AND FLU AND NIGHT COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl, acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9617
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9617-644 in 1 CARTON06/26/2023
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 BLISTER PACK 24   in 6 
Part 24 BLISTER PACK 16   in 4 
Part 1 of 2
DAY COLD AND FLU 
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, coated
Product Information
Item Code (Source)NDC:0363-9615
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorred (Light red to red) Scoreno score
ShapeOVAL (Capsule shaped) Size19mm
FlavorImprint Code D1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/26/2023
Part 2 of 2
NIGHT SEVERE COLD AND FLU 
acetaminophen, dextromethorphan hbr, phenylephrine hcl, triprolidine hcl tablet, coated
Product Information
Item Code (Source)NDC:0363-9616
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
TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Coloryellow (Light golden yellow to Golden yellow) Scoreno score
ShapeOVAL (Capsule shaped) Size19mm
FlavorImprint Code N1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/26/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/26/2023
Labeler - WALGREENS (008965063)
Registrant - TIME CAP LABORATORIES, INC. (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Ltd925822975manufacture(0363-9617)

Revised: 6/2023
Document Id: ff1b08ae-2a15-1a6c-e053-6294a90a6efc
Set id: f3770976-de73-52b8-e053-2995a90aad4f
Version: 2
Effective Time: 20230627
 
WALGREENS