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cold (acetaminophen 325 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed



IMPRINT: L393     SHAPE: capsule
    COLOR: blue

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Active Ingredient (in Each Caplet) (nighttime)


Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose (nighttime)


Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses (nighttime)

  • •temporarily relieves these common cold symptoms:
  • •minor aches and pains
  • •headache
  • •sore throat
  • •nasal congestion
  • •cough
  • •sneezing and runny nose
  • •helps clear nasal passages
  • •relieves cough to help you sleep
  • •temporarily reduces fever

Warnings (nighttime)


Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
  • •more than 12 caplets 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.
  • •to make a child sleepy

Ask a doctor before use if you have

  • •liver disease
  • •heart disease
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •trouble urinating due to an enlarged prostate gland
  • •cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem such as emphysema or chronic bronchitis
  • •glaucoma

Ask a doctor or pharmacist before use if you are

  • •taking sedatives or tranquilizers
  • •taking the blood thinning drug warfarin

When using this product

  • •do not exceed recommended dosage
  • •excitability may occur, especially in children
  • •marked drowsiness may occur
  • •alcohol, sedatives and tranquilizers may increase drowsiness
  • •avoid alcoholic drinks
  • •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
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occur
  • •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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions (nighttime)

  • •do not take more than directed (see Liver warning)
  • •do not take the Day and Night caplets at the same time
  • •do not take more than a total of 12 caplets in 24 hours
take 2 caplets every 4-6 hours
  • swallow whole – do not crush, chew or dissolve

    adults and children 12 years and over
    • •

    children under 12 years

    do not use this adult product in children under 12 years of age

    Inactive Ingredients (nighttime)


    acesulfame potassium, blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide

    Questions Or Comments? (nighttime)


    1-800-632-6900

    Active Ingredient (in Each Caplet) (daytime)


    Acetaminophen 325 mg

    Dextromethorphan HBr 10 mg

    Phenylephrine HCl 5 mg

    Purpose (daytime)


    Pain reliever/fever reducer

    Cough suppressant

    Nasal decongestant

    Uses (daytime)

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

    Warnings (daytime)


    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
    • •more than 12 caplets 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
    • •heart disease
    • •high blood pressure
    • •thyroid disease
    • •diabetes
    • •trouble urinating due to an enlarged prostate gland
    • •cough that lasts or is chronic 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

    When using this product


    do not use more than directed

    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
    • •fever gets worse or lasts more than 3 days
    • •redness or swelling is present
    • •new symptoms occur
    • •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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Directions (daytime)

    • •do not take more than directed (see Liver warning)
    • •do not take the Day and Night caplets at the same time
    • •do not take more than a total of 12 caplets in 24 hours
    take 2 caplets every 4 hours
  • swallow whole – do not crush, chew or dissolve

    adults and children 12 years and over
    • •

    children under 12 years

    do not use this adult product in children under

    12 years of age

    Inactive Ingredients (daytime)


    acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide

    Questions Or Comments? (daytime)


    1-800-632-6900

    Principal Display Panel


    COOL ICE®

    INSTANT COOLING SENSATION

    COMPARE TO active ingredients of TYLENOL® COLD MULTI-SYMPTOM DAY & NIGHT CAPLETS

    See end panel

    DAY / NIGHT COMBO PACK

    Cold

    SEE NEW WARNINGS INFORMATION

    Multi-Symptom

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

    Save when you buy DayTime and Night Time

    NON-DROWSY

    DAYTIME

    Pain Reliever/Fever Reducer/Nasal Decongestant/Cough Suppressant

    Acetaminophen/Dextromethorphan HBr/Phenylephrine HCl

    Fever/Headache/Sore Throat

    Nasal Congestion

    Coughing

    NIGHT TIME

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

    Acetaminophen/Chlorpheniramine Maleate/Dextromethorphan HBr/Phenylephrine HCl

    Fever/Headache/Sore Throat

    Nasal Congestion

    Coughing

    Runny Nose

    *Antihistamine in Nighttime Only
    Cold Carton Image 1 Cold Carton Image 1
    Cold Carton Image 2

    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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