FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
For occasional use only
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
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in children under 12 years
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as a substitute for sleep
fatigue or drowsiness persists or continues to recur
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
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in children under 12 years
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as a substitute for sleep
fatigue or drowsiness persists or continues to recur
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
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Maximum Strength Stay Awake Manufacturers
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Safeway
Maximum Strength Stay Awake | Amneal Pharmaceuticals Of New York, Llc
It is important that Promethazine HCl, Phenylephrine HCl and Codeine Phosphate Syrup, USP is measured with an accurate measuring device [see PRECAUTIONS, Information for Patients]. A household teaspoon is not an accurate measuring device and could lead to overdosage, especially when half a teaspoon is to be measured. It is strongly recommended that an accurate measuring device be used. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose.
The combination of promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate is contraindicated in pediatric patients less than 6 years of age, because the combination may cause fatal respiratory depression in this age population.
The average effective dose for adults and children 12 years of age and over) is 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
The average effective dose for children 6 years to under 12 years of age is ½ to 1 teaspoonful (2.5 mL to 5 mL) every 4 to 6 hours, not to exceed 30 mL in 24 hours.
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