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CounterAct (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg) Dailymed

  1. Human OTC
  2. Archived
    • May Be Discontinued
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  3. Melaleuca, Inc.

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci

CounterAct tablet, film coated - (acetaminophen 325 mg / dextromethorphan hydrobromide 10 mg / guaifenesin 200 mg / phenylephrine hydrochloride 5 mg) image

IMPRINT: 44 503     SHAPE: capsule
    COLOR: yellow

  1. FDA Adverse Reactions

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Otc - Active Ingredient Section


Active ingredients (in each caplet) Acetaminophen 325 mgDextromethophen HBr 10 mgGuaifenesin 200 mgPhenylephrine HCI 5 mg

Otc - Purpose Section


Purpose Pain reliever/fever reducerCough suppressantExpectorantNasal decongestant

Indications & Usage Section


Use
  • temporarily relieves these common cold/flu symptoms:
    • headache
    • minor aches and pains
    • sore throat
    • nasal congestion
    • cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

Warnings Section


Warnings

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompained or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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

Otc - Do Not Use Section


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.

Otc - Ask Doctor Section


Ask a doctor before use if you have
  • liver disease
  • diabetes
  • heart disease
  • high blood pressure
  • thyroid disease
  • 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)

Otc - Ask Doctor/pharmacist Section


Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin

Otc - When Using Section


When using this product
  • do not exceed recommended dosage

Otc - Stop Use Section


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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition

Otc - Pregnancy Or Breast Feeding Section


If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children Section


Keep out of reach of children.

Overdosage Section


Overdose warning:  Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Dosage & Administration Section


Directions
  • do not take more than directed (see overdose warning)
  • adults and children 12 years and older
    • take 2 caplets every 4 hours
    • swallow whole - do not crush, chew, or dissolve
    • do not take more than 12 caplets in 24 hours
  • children under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Storage And Handling Section


Other information
  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive Ingredient Section


Inactive ingredients  corn starch, crospovidone, D and C yellow No. 10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talic, titanium dioxide

Otc - Questions Section


Questions or comments?  1-800-426-9391

Package Label.principal Display Panel


Package Label.principal Display Panel


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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