Alert Tablet, Film Coated
FDA Label NDC 49483-343

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Labs, Inc for the product Alert (NDC 49483-343). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, other safety information, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each tablet)Caffeine 200 mg

Otc - Purpose

PurposeAlertness aid

Indications & Usage

Useshelps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WarningsFor occasional use only

Otc - Do Not Use

Do not use
  • in children under 12 years of age
  • as a substitute for sleep

Other Safety Information

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.

Otc - Stop Use

Stop use and ask a doctor if fatigue, or drowsiness persists or continues to recur

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions
  • adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours

Storage And Handling

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

Inactive Ingredient

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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