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Cold DayTime, Multi-Symptom, Non-drowsy

Medically reviewed on Aug 9, 2017

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: Walgreen Company
NDC Code: 0363-0560

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.

Walgreens 44-560

Active ingredients (in each gelcap)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • nasal congestion
    • headache
    • cough
    • sinus congestion and pressure
    • sore throat
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 gelcaps (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take:

  • 3 or more alcoholic drinks every day while using this product 
  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, 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.

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
  • persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache

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 take more than directed (see overdose warning)
  • adults and children 12 years and over
    • take 2 gelcaps every 4 hours
    • do not take more than 10 gelcaps in 24 hours
    • swallow whole; do not crush, chew or dissolve
  • children under 12 years: ask a doctor

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)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Well at
Walgreens

WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-0560-07

DAYTIME
MULTI-SYMPTOM
NON-DROWSY
Cold
Acetaminophen /
Fever / Headache / Sore Throat
Dextromethorphan HBr / Coughing
Phenylephrine HCl / Nasal Congestion

• Pain reliever, fever reducer, cough suppressant &
nasal decongestant
• Fast-release Quick Gels™

36
GELCAPS
(24+12 FREE)

Actual Size

Compare to Tylenol® Cold
Multi-Symptom Daytime Rapid
Release Gels active ingredientsǂǂ

PSEUDOEPHEDRINE FREE

ǂWalgreens Pharmacist Survey Study, November 2012.

ǂǂThis product is not manufactured or distributed by
McNeil Consumer Healthcare, owner of the registered
trademark Tylenol® Cold Multi-Symptom Daytime Rapid Release Gels.

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

50844    REV1113B56007

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

Walgreens
100% SATISFACTION GUARANTEED

walgreens.com  ©2014 Walgreen Co.

Walgreens 44-560

COLD  DAYTIME, MULTI-SYMPTOM, NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0560
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE GLYCOL 
STEARIC ACID 
TITANIUM DIOXIDE 
FERROSOFERRIC OXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
Product Characteristics
ColorRED, PURPLEScoreno score
ShapeOVALSize19mm
FlavorImprint CodeL;0
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0560-082 BLISTER PACK in 1 CARTON
112 TABLET in 1 BLISTER PACK
2NDC:0363-0560-073 BLISTER PACK in 1 CARTON
212 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/29/2008
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-0560)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0363-0560)

 
Walgreen Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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