CARE ONE COLD HEAD CONGESTION DAYTIME NON-DROWSY- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
American Sales Company
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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American Sales Company Cold Head Congestion Drug Facts
Active ingredient (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
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- temporarily relieves these common cold symptoms:
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- cough
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- sore throat
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- headache
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- minor aches and pains
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- nasal congestion
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- sinus congestion and pressure
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- helps clear nasal passages
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 12 caplets in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
Ask a doctor before use if you have
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- liver disease
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- high blood pressure
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- diabetes
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- heart disease
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- trouble urinating due to an enlarged prostate gland
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
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- thyroid disease
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- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion or cough gets worse or lasts more than 7 days
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- new symptoms occur
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
Directions
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- do not take more than directed (see Liver warning)
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adults and children 12 years and over |
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children under 12 years |
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Inactive ingredients
acesulfame potassium, carnauba wax, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, starch, stearic acid, talc, titanium dioxide
Principal Display Panel
Compare to the Active Ingredients in Tylenol® Cold Head Congestion Daytime
Daytime
Non-Drowsy
Cold
Head Congestion
Pain Reliever, Cough Suppressant, Nasal Decongestant
Headache/Sore Throat – Acetaminophen
Nasal Congestion – Phenylephrine HCl
Coughing – Dextromethorphan HBr
Instant Cooling Sensation
See New Warnings Information
Cold Head Congestion Carton Image 2
| CARE ONE COLD HEAD CONGESTION
DAYTIME NON-DROWSY
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated |
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| Labeler - American Sales Company (809183973) |