Label: MULTI-SYMPTOM DAYTIME COLD - acetaminophen, dextromethorphan hydrobromide and phenylephrine hydrochloride capsule, liquid filled 

  • Label RSS
  • NDC Code(s): 63981-560-46
  • Packager: COSTCO WHOLESALE CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/10

If you are a consumer or patient please visit this version.

  • Drug Facts
  • Active ingredients

    (in each gelcap)

    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

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  • Purpose

    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

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  • Uses

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

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  • 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 presciption 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.
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  • Ask a doctor before use if you have

    • liver disease
    • diabetes
    • heart disease
    • thyroid disease
    • trouble urinating due to an enlarged prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
    • high blood pressure
    • cough that occurs with too much phlegm (mucus)
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  • Ask a doctor or pharmacist before use if you are

    • taking the blood thinning drug warfarin
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  • When using this product

    • do not exceed recommended dosage
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  • Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • new symptoms 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
    • cough comes back or occurs with rash or headache that lasts

    These could be signs of a serious condition.

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  • If pregnant or breast-feeding,

    ask a health professional before use.

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  • 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.

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  • 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
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  • Other information

    • store at controlled room temperature 15°-30°C (59°-86°F)
    • see end flap for expiration date and lot number
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  • 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

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  • Questions or comments?

    1-800-774-2678

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  • 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-SYMPTOMS DAYTIME

    active ingredients*

    NDC 63981-560-46

    ITEM #532129

    DAYTIME

    NON-DROWSY

    COLD

    MULTI-SYMPTOM

    Acetaminophen 325 mg,

    Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

    Pain Reliever/Fever Reducer,

    Nasal Decongestant, Cough Suppressant

    See New Warnings Information

    Temporarily Relieves:

    √ Fever / Headache / Sore Throat

    √ Nasal Congestion

    √ Coughing

    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                 ORG100956046

    Manufactured 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

    Product Label
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  • INGREDIENTS AND APPEARANCE
    MULTI-SYMPTOM DAYTIME COLD  
    acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63981-560
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (Acetaminophen) Acetaminophen 325 mg
    Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 10 mg
    Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 5 mg
    Inactive Ingredients
    Ingredient Name Strength
    Croscarmellose Sodium  
    Crospovidone  
    D&c Red No. 28  
    Fd&c Blue No. 1  
    Fd&c Red No. 40  
    Gelatin  
    Hydroxypropyl Cellulose  
    HYPROMELLOSES  
    Ferrosoferric Oxide  
    Ferric Oxide Yellow  
    Magnesium Stearate  
    Cellulose, Microcrystalline  
    Polyethylene Glycol  
    Povidone  
    Propylene Glycol  
    Silicon Dioxide  
    Stearic Acid  
    Titanium Dioxide  
    Product Characteristics
    Color RED (Lavender) Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 44;560
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63981-560-46 1 in 1 CARTON
    1 96 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 03/29/2008
    Labeler - COSTCO WHOLESALE CORPORATION (103391843)
    Registrant - L.N.K. International, Inc. (832867837)
    Establishment
    Name Address ID/FEI Business Operations
    L.N.K. International, Inc 832867894 MANUFACTURE
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