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Cold Relief (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) Dailymed

  1. Human OTC
  2. Archived
  3. COSTCO WHOLESALE CORPORATION

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl

Cold Relief kit - (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet) image
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acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / phenylephrine hydrochloride 5 mg oral tablet - l 0 oval red

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerCough suppressantNasal decongestant 

Uses

  • temporarily relieves these common cold/flu symptoms:
    • headache
    • nasal congestion
    • cough
    • sore throat
    • minor aches and pains
    • sinus congestion and pressure
  • 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:
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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. 
  • 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
  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • high blood pressure
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough that occurs with too much phlegm (mucus) 
  • thyroid disease
  • diabetes

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 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

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

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 

Active Ingredients (in Each Caplet)


Acetaminophen 325 mgChlorpheniramine maleate 2 mgDextromethorphan HBr 10 mgPhenylephrine 5 mg

Purpose


Pain reliever/fever reducerAntihistamineCough suppressantNasal decongestant

Uses

  • temporarily relieves these common cold/flu symptoms:
    • cough
    • sore throat
    • nasal congestion
    • minor aches and pains
    • headache
    • 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. The maximum daily dose of this product is 10 gelcaps (3,250 mg acetaminophen). Severe liver damage may occur if you take:
  • more than 4,000 mg of acetaminophen in 24 hours
  • 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.
  • 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
  • trouble urinating due to an enlarged prostate gland
  • high blood pressure
  • 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 phlegm (mucus)  
  • thyroid disease

Aska 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
  • 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

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

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, silica gel, simethicone, stearic acid, titanium dioxide, yellow iron oxide

Principal Display Panel


KIRKLAND Signature ™

COMPARE TO TYLENOL® COLD MULTI SYMPTOM DAYTIME active ingredients*

DAYTIMENON-DROWSY COLDMULTI-SYMPTOM

Acetaminophen 325 mg, Dextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Pain Reliever/Fever Reducer,Nasal Decongestant, Cough Suppressant

Temporarily Relieves:Fever/Headache/Sore ThroatNasal CongestionCoughing

2x60 Rapid Release Gelcaps
KIRKLAND Signature ™

COMPARE TO TYLENOL® COLD MULTI SYMPTOM NIGHTTIME active ingredients*

NDC 63981-701-81ITM./ART.719938

NIGHTTIME COLDMULTI-SYMPTOM Acetaminophen 325 mg, Chlorpheniramine maleate 2 mgDextromethorphan HBr 10 mg, Phenylephrine HCl 5 mg

Pain Reliever/Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine

Temporarily Relieves:Fever/Headache/Sore ThroatNasal CongestionCoughingRunny Nose

48 Rapid Release Gelcaps
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Cold Multi-Symptom Daytime & Nighttime.50844    ORG1113.560/1213.591B81

This product does not contain gluten.

Manufactured by: LNK INTERNATIONAL, INC.60 Arkay Drive, Hauppauge, NY 11788 USA

For: Costco Wholesale CorporationP.O. Box 34535 Seattle, WA 98124-1535 USA1-800-774-2678www.costco.com13V101092b

ITM. / ART.719938 Kirkland 44-560591

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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