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

  1. Human OTC
  2. Archived
  3. Meijer Distribution Inc

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride

cold relief tablet, film coated - (acetaminophen 325 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: L393     SHAPE: capsule
    COLOR: blue

  1. FDA Adverse Reactions

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Active Ingredient (in Each Caplet)


Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Uses

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

Warnings


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
  • •persistent or chronic cough 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 the blood thinning drug warfarin
  • •taking sedatives or tranquilizers

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

  • •do not take more than directed (see Liver warning)
take 2 caplets every 4-6 hours
    • swallow whole – do not crush, chew or dissolve
    • do not take more than 12 caplets in 24 hoursdo not use this adult product in children under 12 years of age

    adults and children 12 years and over
    • • •

    children under 12 years
    •

    Inactive Ingredients


    acesulfame potassium, {FD&C} blue no. 1 aluminum 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?


    1-800-719-9260

    Principal Display Panel


    Compare to Tylenol® Cold Multi-Symptom Nighttime active ingredients

    See New Warnings Information

    Cool Ice® Caps

    Instant Cooling Sensation

    Cold Relief

    Pain Reliever/Fever Reducer, Nasal Decongestant,

    Cough Suppressant, Anihistamine

    Multi-Symptom

    Fever / Headache / Sore Throat - Acetaminophen

    Runny Nose - Chlorpheniramine Maleate

    Coughing - Dextromethorphan HBr

    Nasal Congestion - Phenylephrine HCl

    NiteTime
    Cold Relief Carton Image 1 Cold Relief Carton Image 1
    Cold Relief 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."

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    "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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