LEADER COLD HEAD CONGESTION- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated
Cardinal Health
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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Cardinal Health Cold Head Congestion Drug Facts
Active ingredient (in each caplet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Uses
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- temporarily relieves these common cold symptoms:
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- minor aches and pains
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- nasal congestion
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- sore throat
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- sneezing and runny nose
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- cough
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- sinus congestion and pressure
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- headache
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- helps clear nasal passages
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- relieves cough to help you sleep
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.
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- to make a child sleepy
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- diabetes
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- thyroid 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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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- high blood pressure
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
When using this product
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- do not use more than directed
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- excitability may occur, especially in children
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- marked drowsiness may occur
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- be careful when driving a motor vehicle or operating machinery
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- avoid alcoholic drinks
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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- redness or swelling is present
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- fever gets worse or lasts more than 3 days
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- cough comes back or occurs with rash or headache that lasts
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- new symptoms occur
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 |
do not use this adult product in children under 12 years of age |
Inactive ingredients
acesulfame potassium, FD&C blue no. 1 lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, talc, titanium dioxide
Principal Display Panel
SEE NEW WARNINGS INFORMATION
Compare to Tylenol® Cold Head Congestion Nighttime active ingredients
Cold Head Congestion
Nighttime
Contains 4 Medicines:
Pain Reliever - Acetaminophen
Nasal Decongestant - Phenylephrine HCl
Cough Suppressant - Dextromethorphan HBr
Antihistamine - Chlorpheniramine Maleate
Headache / Sore Throat
Runny Nose - Coughing
Nasal Congestion
Instant Cooling Sensation
Cool Ice®
Cold Head Congestion Carton Image 2
| LEADER COLD HEAD CONGESTION
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride tablet, film coated |
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| Labeler - Cardinal Health (097537435) |