severe cold (acetaminophen 325 mg dextromethorphan hydrobromide 10 mg guaifenesin 200 mg phenylephrine hydrochloride 5 mg) Dailymed
IMPRINT: L234
SHAPE: oval
COLOR: yellow
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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• sore throat• cough• headache• nasal congestion• 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 ingredientsAsk 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.
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)
adults and children 12 years and over
• take 2 caplets every 4 hours• swallow whole – do not crush, chew or dissolve• do not take more than 10 caplets in 24 hours
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
Principal Display Panel
SEE NEW WARNINGS INFORMATION
severe cold
ACETAMINOPHEN - HEADACHE/SORE THROAT
PHENYLEPHRINE HCl - NASAL CONGESTION
DEXTROMETHORPHAN HBr - COUGHING
GUAIFENESIN - CHEST CONGESTION
pain reliever/fever reducer
nasal decongestant
cough suppressant
expectorant
ACTUAL SIZE
24 CAPLETS
Compare to the Active Ingredients in Tylenol® Cold Head Congestion Severe
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"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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