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Leader severe cold and flu (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
  3. Cardinal Health

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl

Leader severe cold and flu tablet, film coated - (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) image
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IMPRINT: L234     SHAPE: oval
    COLOR: yellow

All Imprints

acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg oral tablet - l234 oval 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
  • •helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • •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

  • •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.


Overdose warning: 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 overdose 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

    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?


    1-800-719-9260

    Principal Display Panel


    Severe Cold & Flu

    Acetaminophen | Dextromethorphan HBr

    Guaifenesin | Phenylephrine HCl

    Pain Reliever / Fever Reducer | Cough Suppressant

    Expectorant | Nasal Decongestant

    COMPARE TO TYLENOL® COLD + FLU SEVERE active ingredients

    100% Money Back Guarantee

    Headache, Fever, Sore Throat

    Nasal Congestion, Cough

    Chest Congestion, Clears out Mucus

    For Adults

    24 CAPLETS

    Actual Size

    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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