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

  1. Human OTC
  2. Archived
  3. L.N.K. International, Inc.

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

Cold Relief kit - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: 44 470     SHAPE: oval
    COLOR: white

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acetaminophen 325 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg - 44 473 oval blue

cold relief multi-symptom (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl) kit - 44 473 oval blue

acetaminophen 325 mgchlorpheniramine maleate 2 mgdextromethorphan hydrobromide 10 mgphenylephrine hydrochloride 5 mg - 44 473 oval blue

acetaminophen 325 mgdextromethorphan hydrobromide 10 mgphenylephrine hydrochloride 5 mg - 44 470 oval white

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)(daytime Cold Multi-symptom)


Acetaminophen 325 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerCough suppressantNasal decongestant

Active Ingredients (in Each Caplet)(nighttime Cold Multi-symptom)


Acetaminophen 325 mgChlorpheniramine maleate 2 mgDextromethorphan HBr 10 mgPhenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducerAntihistamineCough suppressantNasal decongestant

Uses

  • temporarily relieves these common cold and flu symptoms:
    • cough
    • sore throat
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • sneezing and runny nose (Nighttime only)
  • helps clear nasal passages
  • relieves cough to help you sleep (Nighttime only)
  • promotes nasal and sinus drainage (Daytime only)
  • temporarily reduces fever

Warnings


Liver warning: This product contains 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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
  • skin reddening
  • bulers
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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

  • diabetes
  • liver disease
  • high blood pressure
  • heart disease
  • glaucoma (Nighttime only)
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • difficulty in urination due to enlargement of the prostate gland
  • thyroid disease
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)

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
  • 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.


In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.

Directions

  • do not take more than directed
  • 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 10 caplets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive Ingredients (daytime Only)


corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide

Inactive Ingredients (nighttime Only)


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, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions Or Comments?


1-800-426-9391

Principal Display Panel


QUALITY + PLUS

NDC 50844-529-02

*Compare to active ingredients in Tylenol® COLD MAX Day & Tylenol® Cold Multi-Symptom Night

MULTI-SYMPTOM COLD RELIEF

Acetaminophen, Dextromethorphan HBr,Phenylephrine HCl

PAIN RELIEVER/FEVER REDUCER,COUGH SUPPRESSANT,NASAL DECONGESTANT

NON-DROWSY

ACTUAL SIZE

6 Caplets

Acetaminophen, Chlorpheniramine maleate,Dextromethorphan HBr,Phenylephrine HCl

PAIN RELIEVER/FEVER REDUCER,ANTIHISTAMINE,COUGH SUPPRESSANT,NASAL DECONGESTANT

ACTUAL SIZE

6 Caplets

                                              12 Total Caplets

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 Johnson & Johnson Corporation, owner of the registered trademark Tylenol® COLD MAX Day & Tylenol® Cold Multi-Symptom Night.50844    REV0718D47047302

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

Quality Plus 44-470C473

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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