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| Product NDC Code | 49483-343 | ||||
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| Drug Name | Alert |
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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, FILM COATED | ||||
| RxCUI drug identifier | 198520 | ||||
| Application Number | part340 | ||||
| Labeler Name | Time Cap Labs, Inc | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Caffeine 200 mg
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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 and over: take 1 tablet not more often than every 3 to 4 hours
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax, colloidal silicon dioxide, D-C yellow #10 aluminum lake, dextrates, FD-C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide
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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.Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
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Purpose
Information about the drug product’s indications for use.Purpose Alertness aid
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Spl product data elements
Usually a list of ingredients in a drug product.Alert Caffeine CARNAUBA WAX SILICON DIOXIDE D&C YELLOW NO. 10 DEXTRATES FD&C YELLOW NO. 6 HYPROMELLOSE 2910 (6 MPA.S) HYPROMELLOSE 2910 (15 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE CAFFEINE CAFFEINE TCL;343
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.IMAGE OF BOTTLE LABEL
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use in children under 12 years of age as a substitute for sleep
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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. In case of overdose, get medical help or contact a Poison Control Center right away.
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Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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 heartbeat.
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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
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Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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Storage and handling
Information about safe storage and handling of the drug product.Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) avoid excessive heat (greater than 100°F) or humidity use by expiration date on package
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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
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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