Nighttime Cold Multi Symptom

Dosage form: capsule, liquid filled
Ingredients: Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan Hydrobromide 10mg, Phenylephrine Hydrochloride 5mg
Labeler: COSTCO WHOLESALE CORPORATION
NDC Code: 63981-591

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.

Drug Facts

Active ingredients

(in each gelcap)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves theses common cold/flu symptoms:
  • minor aches and pains
  • headache
  • nasal congestion
  • cough
  • sneezing and runny nose
  • sore throat
  • sinus congestion and pressure
  • 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 gelcaps 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, 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
  • diabetes
  • heart disease
  • glaucoma
  • high blood pressure
  • thyroid disease
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • persistant 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
  • taking sedatives or tranquilizers

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

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
  • cough comes back or occurs with rash or headache that lasts. 
  • redness or swelling is present

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 gelcaps every 4 hours
  • do not take more than 12 gelcaps 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 controlled room temperature 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-774-2678

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

KIRKLAND

Signature™

COMPARE TO TYLENOL®

COLD MULTI-SYMPTOM NIGHTTIME

active ingredients*

NDC 63981-591-46

ITEM #532129

NIGHTTIME

COLD

MULTI-SYMPTOM

Acetaminophen 325 mg, Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Pain Reliever/Fever Reducer, Nasal Decongestant,

Cough Suppressant, Antihistamine

See new Warnings Information

Temporarily Relieves:

√ Fever/Headache/Sore Throat

√ Nasal Congestion

√ Coughing

√ Runny Nose

Actual Size

96

Rapid Release Gelcaps

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

50844       ORG081059146

Mnufactured by: LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788 USA

For Costco Wholesale Corporation

P.O. Box 34535

Seattle, WA 98124-1535 USA

1-800-774-2678

www.costco.com

NIGHTTIME COLD MULTI SYMPTOM  
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-591
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
Ammonia 
Ferrosoferric Oxide 
Croscarmellose Sodium 
Crospovidone 
Fd&c Blue No. 1 
Fd&c Red No. 40 
Gelatin 
Hydroxypropyl Cellulose 
HYPROMELLOSES 
Magnesium Stearate 
Cellulose, Microcrystalline 
Polyethylene Glycol 
Povidone 
Silicon Dioxide 
Dimethicone 
Stearic Acid 
Titanium Dioxide 
Ferric Oxide Yellow 
Product Characteristics
ColorBLUE (Dark Blue, Grey) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code44;591
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-591-461 BLISTER PACK (BLISTER PACK) in 1 CARTON
196 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/25/2010
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
NameAddressID/FEIOperations
L.N.K. International, Inc832867894MANUFACTURE

Revised: 09/2010
 
COSTCO WHOLESALE CORPORATION

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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