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Topcare Cold Head Congestion (acetaminophen 325 mg chlorpheniramine maleate 2 mg dextromethorphan hydrobromide 10 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Topco Associates LLC

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

Topcare Cold Head Congestion 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

Antihistamine

Cough suppressant

Nasal decongestant

Uses

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

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
  • •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 use more than directed
  • •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

  • •you get nervous, dizzy or sleepless
  • •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 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?


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    Principal Display Panel


    See New Warnings Information

    Nighttime

    Cold Head Congestion

    Pain Reliever, Nasal Decongestant, Cough Suppressant, Antihistamine

    Contains 4 Medicines:

    Headache/Sore Throat /Acetaminophen

    Nasal Congestion/Phenylephrine HCl

    Coughing/Dextromethorphan HBr

    Runny Nose/Chlorpheniramine Maleate

    Instant Cooling Sensation

    Cool Ice®

    Compare to Tylenol® Cold Head Congestion Nighttime active ingredients

    Actual size
    Cold Head Congestion Carton
    Cold Head Congestion Carton

    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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