COLD AND FLU SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated 
Walgreen Company

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Walgreens 44-640

Active ingredients (in each caplet)

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

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
  • thyroid disease
  • diabetes
  • heart disease
  • high blood pressure
  • 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

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product

do not exceed recommended dosage.

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.

Directions

Other information

Inactive ingredients

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Walgreens
Compare to the active ingredients in
Vicks® DayQuil® Severe Cold & Flu††
• WALGREENS •
PHARMACIST RECOMMENDED

NDC 0363-0640-08

DAY

Severe
Cold & Flu

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Maximum Strength

• Relieves headache, fever, sore throat, minor aches & pains,
chest congestion, thins & loosens mucus, nasal
congestion, sinus pressure & cough

24
CAPLETS

ACTUAL SIZE

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

Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured or
distributed by The Procter & Gamble
Company, owner of the registered
trademark Vicks® DayQuil® Severe Cold
& Flu.

50844 REV0722A64008

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED
walgreens.com   
©2021 Walgreen Co.

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Walgreens 44-640

Walgreens 44-640

COLD AND FLU  SEVERE
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0640
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, UNSPECIFIED (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)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POVIDONE, UNSPECIFIED (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
ColororangeScoreno score
ShapeOVALSize19mm
FlavorImprint Code 44;640
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0640-082 in 1 CARTON02/27/2014
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01202/27/2014
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(0363-0640) , pack(0363-0640)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(0363-0640)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(0363-0640)

Revised: 1/2024
Document Id: 491daf39-285c-4fd4-a1df-c5f25f648d57
Set id: 93d5b1db-e9ad-4a6a-b869-fd0d1a11df02
Version: 17
Effective Time: 20240115
 
Walgreen Company