FDA records indicate that there are no current recalls for this drug.
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Nitetime Daytime 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 4 doses (2,600 mg acetaminophen) in 24 hours (Nighttime) and 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours (Daytime). Severe liver damage may occur if
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- adult takes more than 4,000 mg of acetaminophen in 24 hours
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- child takes more than 5 doses in 24 hours, which is the maximum daily amount
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- more than 4,000 mg of acetaminophen in 24 hours
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- taken with other drugs containing acetaminophen
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- adult has 3 or more alcoholic drinks every day while using this product
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.
- •
- 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 (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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- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough as occurs with smoking, asthma, or emphysema
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- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
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- glaucoma (Nighttime only)
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- a sodium-restricted diet (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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- marked drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- be careful when driving a motor vehicle or operating machinery
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- you get nervous, dizzy or sleepless (Daytime only)
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- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) (Daytime only)
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- pain or cough gets worse or lasts more than 7 days (Nighttime only)
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- fever gets worse or lasts more than 3 days
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- new symptoms occur
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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.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- •
- 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.
- •
- 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)
- •
- trouble urinating due to an enlarged prostate gland
- •
- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
- •
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- •
- glaucoma (Nighttime only)
- •
- a sodium-restricted diet (Nighttime only)
- •
- taking sedatives or tranquilizers (Nighttime only)
- •
- taking the blood thinning drug warfarin
- •
- you get nervous, dizzy or sleepless (Daytime only)
- •
- pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) (Daytime only)
- •
- pain or cough gets worse or lasts more than 7 days (Nighttime only)
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- redness or swelling is present
- •
- 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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- nasal congestion (Daytime only)
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- sore throat
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- headache
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- cough due to minor throat and bronchial irritation
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- fever
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- minor aches and pains
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- runny nose and sneezing (Nighttime only)
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Nitetime Daytime Manufacturers
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Kroger Company
Nitetime Daytime | Kroger Company
• take only as directed - see Liver warning • take Nighttime or Daytime • use dose cup • do not exceed 4 doses per 24 hrsNighttime
adults & children 12 yrs & over
30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
Daytimeadults & 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
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing -
Kroger Company
Nitetime Daytime | Kroger Company
• take only as directed - see Liver warning • take Nighttime or Daytime • use dose cup • do not exceed 4 doses per 24 hrsNighttime
adults & children 12 yrs & over
30 ml (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
Daytime
adults & 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
• when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
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