FDA records indicate that there are no current recalls for this drug.
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Rexall Daytime Nighttime Cold Flu Recall
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: These products contain acetaminophen. The maximum daily dose of these products is 8 softgels (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using these products
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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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 these products.
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- to make a child sleepy (Nighttime only)
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- if you have ever had an allergic reaction to these products or any of their ingredients
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- liver disease
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- heart disease (Daytime only)
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- thyroid disease (Daytime only)
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- diabetes (Daytime only)
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- high blood pressure (Daytime only)
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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 (Nighttime only)
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
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- trouble urinating due to an enlarged prostate gland
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- glaucoma (Nighttime only)
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- taking sedatives or tranquilizers (Nighttime only)
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- taking the blood thinning drug warfarin
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- do not use more than directed
In addition, when using Nighttime:
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- excitability may occur, especially in children
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- may cause marked drowsiness
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- you get nervous, dizzy or sleepless (Daytime only)
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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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- new symptoms occur
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- pain, nasal congestion or cough gets worse or lasts more than 7 days
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
ask a health professional before 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 these products.
- •
- to make a child sleepy (Nighttime only)
- •
- if you have ever had an allergic reaction to these products or any of their ingredients
- •
- liver disease
- •
- heart disease (Daytime only)
- •
- thyroid disease (Daytime only)
- •
- diabetes (Daytime only)
- •
- high blood pressure (Daytime only)
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- •
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- •
- trouble urinating due to an enlarged prostate gland
- •
- glaucoma (Nighttime only)
- •
- taking sedatives or tranquilizers (Nighttime only)
- •
- taking the blood thinning drug warfarin
- •
- you get nervous, dizzy or sleepless (Daytime only)
- •
- redness or swelling is present
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- pain, nasal congestion or cough gets worse or lasts more than 7 days
- •
- cough comes back or occurs with rash or headache that lasts. 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 common cold/flu symptoms:
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- cough due to minor throat and bronchial irritation
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- sore throat
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- headache
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- minor aches and pains
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- fever
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- relieves runny nose and sneezing (Nighttime only)
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- nasal congestion (Daytime only)
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Rexall Daytime Nighttime Cold Flu Manufacturers
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Dolgencorp, Llc
Rexall Daytime Nighttime Cold Flu | Wakefern Food Corporation
• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrsadults & children 12 yrs & over
30 mL (2 TBSP) every 4 hrs
children 6 to under 12 yrs
15 mL (1 TBSP) every 4 hrs
children 4 to under 6 yrs
ask a doctor
children under 4 yrs
do not use
Other information • each 15 mL tablespoon contains: sodium 6 mg • store at 20-25°C (68-77°F) Do not refrigerate.
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