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Topcare Cold Multi Symptom Severe (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed

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

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

Topcare Cold Multi Symptom Severe tablet, film coated - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image

IMPRINT: L234     SHAPE: oval
    COLOR: yellow

  1. FDA Adverse Reactions

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Active Ingredients (in Each Caplet)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose


Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • •for the temporary relief of the following cold/flu symptoms:
  • •minor aches and pains
  • •headache
  • •sore throat
  • •nasal congestion
  • •cough
  • •impulse to cough
  • •helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • •temporarily reduces fever

Warnings


Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (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
  • •high blood pressure
  • •thyroid disease
  • •diabetes
  • •trouble urinating due to an enlarged prostate gland
  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis 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 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
  • •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 hours
    • swallow whole – do not crush, chew or dissolve
    • do not take more than 10 caplets in 24 hours

    adults and children 12 years and over
    • • •

    children under 12 years
    ask a doctor

    Other Information

    • •each caplet contains: sodium 3 mg
    • •store at 20-25oC (68-77oF)

    Inactive Ingredients


    acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

    Questions Or Comments?


    1-888-423-0139

    Principal Display Panel


    SEE NEW WARNINGS AND DIRECTIONS

    DAYTIME – NON-DROWSY

    Cold

    Multi-Symptom

    Severe

    PAIN RELIEVER – FEVER REDUCER

    NASAL DECONGESTANT / COUGH SUPPRESSANT

    EXPECTORANT

    Contains 4 Medicines:

    Fever / Headache / Sore Throat / Acetaminophen

    Nasal Congestion / Phenylephrine HCl

    Coughing / Dextromethorphan HBr

    Chest Congestion / Guaifenesin

    Instant Cooling Sensation

    COOL ICE®

    actual size

    COMPARE TO TYLENOL® COLD MULTI-SYMPTOM SEVERE active ingredients

    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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