FDA records indicate that there are no current recalls for this drug.
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Severe Congestion And Cough/cold And Flu Daytime/nighttime/maximum Strength Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
- if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
- heart disease
- liver disease (Nighttime only)
- diabetes
- thyroid disease (Nighttime only)
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus) (Daytime only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic drinks (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- be careful when driving a motor vehicle or operating machinery (Nighttime only)
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever (Daytime only)
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache (Daytime only)
- redness or swelling is present (Nighttime only)
- pain or nasal congestion gets worse or lasts more than 7 days (Nighttime only)
- fever gets worse or lasts more than 3 days (Nighttime only)
- new symptoms occur (Nighttime only)
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
- if you have ever had an allergic reaction to this product or any of its ingredients (Nighttime only)
- heart disease
- liver disease (Nighttime only)
- diabetes
- thyroid disease (Nighttime only)
- glaucoma
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus) (Daytime only)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever (Daytime only)
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash or persistent headache (Daytime only)
- redness or swelling is present (Nighttime only)
- pain or nasal congestion gets worse or lasts more than 7 days (Nighttime only)
- fever gets worse or lasts more than 3 days (Nighttime only)
- new symptoms occur (Nighttime only)
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves:
- cough due to minor and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves these symptoms of hay fever and the common cold:
- headache
- sneezing
- runny nose
- sore throat
- minor aches and pains
- nasal congestion
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Severe Congestion And Cough/cold And Flu Daytime/nighttime/maximum Strength Manufacturers
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Woonsocket Prescription Center,incorporated
Severe Congestion And Cough/cold And Flu Daytime/nighttime/maximum Strength | Woonsocket Prescription Center,incorporated
do not take more than 12 caplets in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use do not use more than directed adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years: do not use
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