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  5. Label Information: Multi-symptom Daytime Cold

FDA Label for Multi-symptom Daytime Cold

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRODUCT PACKAGING

Multi-symptom Daytime Cold Product Label

The following document was submitted to the FDA by the labeler of this product Costco Wholesale Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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
  • headache
  • nasal congestion
  • cough
  • sore throat
  • sinus congestion and pressure
  • helps clear nasal passages
  • promotes nasal and sinus drainage
  • 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 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.

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)

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
  • 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.


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



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?



1-800-774-2678


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-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


* Please review the disclaimer below.