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Nighttime Multi-Symptom Cold

Dosage form: capsule
Ingredients: ACETAMINOPHEN 325mg, CHLORPHENIRAMINE MALEATE 2mg, DEXTROMETHORPHAN HYDROBROMIDE 10mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: WALGREEN CO.
NDC Code: 0363-4730

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 44-473C-Delisted

Active ingredients (in each caplet)

Acetaminophen 325 mg
Chlorpheniramine maelate 2 mg
Dextromethorphan HBr  10 mg
Phenylephrine HCl 5 mg 

Purpose

Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant 

Uses
  • temporarily relieves these common cold/flu symptoms:
    • minor aches and pains
    • headache
    • nasal congestion
    • cough
    • sore throat
    • sinus congestion and pressure
    • sneezing and runny nose
  • helps clear nasal passages
  • relieves cough to help you sleep
  • temporarily reduces fever 

Warnings

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

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

Sore throat warning: If sore throat is severe, presists for more than 2 days, is accompained 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, ask a doctor or pharmacist before taking this product.

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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlem (mucus) 

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers 

When using this product
  • do not exceed recommended dosage
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • be careful when driving a motor vehicle or operating machinery
  • marked drowsiness may occur 

Stop use and ask a doctor if
  • nervousness, diziness, 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.

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. 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 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information
  • store at 25ºC (77ºC); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal display panel

Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDEDǂ

NDC 0363-4370-08

NIGHTTIME
MULTI-SYMPTOM
Cold
Acetaminophen
/
Fever / Headache / Sore Throat
Phenyelphrine HCl / Nasal Congestion
Dextromethorphan HBr / Coughing
Chlorpheniramine Maleate / Runny Nose
• Pain reliever, fever reducer, nasal decongestant, cough suppressant, antihistamine

24
CAPLETS

Compare to Tylenol® Cold Multi-Symptom Nighttime Caplets active ingredientsǂǂ

PSEUDOEPHEDRINE FREE • COOL BLAST FLAVOR

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

ǂWalgreens Pharmacist Survey Study, November 2010.
ǂǂThis product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Nighttime.
50844    REV0612A47308

Walgreens 44-473C

NIGHTTIME MULTI-SYMPTOM COLD 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4730
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE2 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
CELLULOSE, MICROCRYSTALLINE 
TALC 
SUCRALOSE 
STARCH, CORN 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize17mm
FlavorMINTImprint Code44;473
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-4730-082 BLISTER PACK in 1 CARTON
112 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/21/200511/05/2018
Labeler - WALGREEN CO. (008965063)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0363-4730)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0363-4730)

Revised: 11/2015
 
WALGREEN CO.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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