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| Product NDC Code | 68210-4151 | ||||
|---|---|---|---|---|---|
| Drug Name | Stay awake |
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| Type | Brand | ||||
| Pharm Class | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET | ||||
| RxCUI drug identifier | 198520 | ||||
| Application Number | M011 | ||||
| Labeler Name | Spirit Pharmaceuticals LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Stay Awake
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.In case of overdose, get medical help or contact a Poison Control Center right away.1(800)222-1222
Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredient (in each tablet) Caffeine 200 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions ■ adults and children 12 years of age and over: take 1 tablet not more often than every 3 to 4 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.carnauba wax*,croscarmellose sodium, colloidal silicon dioxide*, dextrates*, D&C yellow #10 aluminum lake, dicalcium phosphate*, FD&C red#40 lake*, FD&C yellow #6 aluminum lake*, hypromellose, lactose*, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide*, titanium dioxide *contains one or more of these ingredients
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use ■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Purpose
Information about the drug product’s indications for use.Purpose Alertness Aid
Spl product data elements
Usually a list of ingredients in a drug product.Stay Awake Caffeine 200 mg Tablets CARNAUBA WAX CROSCARMELLOSE SODIUM SILICON DIOXIDE D&C YELLOW NO. 10 ALUMINUM LAKE DEXTRATES ANHYDROUS DIBASIC CALCIUM PHOSPHATE FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE CAFFEINE CAFFEINE ET38;AZ076;TCL343
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Stay Awake Caffeine 200 mg - alertness aid safe and effective 20 Tablets Display panel
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Other information ■ store at room temperature ■ avoid excessive heat (greater than 100°F) or humidity
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-888-333-9792
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product limit the use of caffeine containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding , ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For occasional use only Do not use ■ in children under 12 years of age ■ as a substitute for sleep
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API