CAR - 1161 - 2019-1001
Drug Labeling and Warnings
Drug Details [pdf]
COLD HEAD CONGESTION NIGHTTIME- acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, 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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CAR - 1161 - 2019-1001
Uses
- temporarily relieves these common cold symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- sneezing and runny nose
- cough
- sinus congestion and pressure
- helps clear nasal passages
- relieves cough to help you sleep
Warnings
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
Allergy alert
acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- 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
- high blood pressure
- heart disease
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
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.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
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| children under 12 years |
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Other information
- store between 20°-25°C (68°-77°F) in a dry place
- retain carton for complete product information
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
NDC: 41520-598-02
CareOne®
For Adults
Cold + Head Congestion
Pain Reliever/Fever Reducer – Acetaminophen
Antihistamine – Chlorpheniramine Maleate
Cough Suppressant – Dextromethorphan HBr
Nasal Decongestant - Phenylephrine HCl
Nighttime
Instant Cooling Sensation
For the Relief of:
Headache & Body Aches
Sore Throat & Fever
Nasal Congestion
Cough
Runny Nose
Our Pharmacists Recommend
24 Cool Taste Caplets
| COLD HEAD CONGESTION NIGHTTIME
acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated |
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| Labeler - American Sales Company (809183973) |