Allertness Aid
FDA Label NDC 52904-470

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Allertness Aid (NDC 52904-470). 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, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients Caffeine 200mg

Otc - Purpose

Alertness Aid

Dosage & Administration

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

Indications & Usage

Uses: helps restore mental alertness or wakefulness when
experiencing fatigue or drowsiness

Warnings

Warnings: Foroccasional use only. Do not use • in children under 12 yearsof age • as a substitute for sleep Caffeine warning: Therecommended dose of this product contains about as muchcaffeine as a cup of coffee. Limit the use of caffeine-containingmedications, foods, or beverages while taking this productbecause too much caffeine may cause nervousness,irritability, sleeplessness, and, occasionally, rapid heart beat.Stop use and ask a doctor if fatigue or drowsiness persists orcontinues 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.

Inactive Ingredient

Inactive
Ingredients: carnauba wax, colloidal silicon
dioxide, dextrates, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, titanium
dioxide

Package Label.Principal Display Panel

MM1

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