Alertness Aid
FDA Label NDC 70005-020

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Alertness Aid (NDC 70005-020). 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 other, otc - purpose, uses, for occasional use only, caffeine warning, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredient (in each tablet)                 Purpose

Caffeine 200 mg........................................Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

For Occasional Use Only

Do not use

■ in children under 12 years of age

■ as a substitute for sleep

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.

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.

Directions

■ adults and children 12 years of age or over: take 1 tablet not more often than every 3 to 4 hours

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

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, D&C yellow no10 aluminum lake, dextrates, FD&C yellow no 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Principal Display Panel

Compare to the Active Ingredients in Vivarin®

ALERTNESS AID

Caffeine Tablets, 200 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each

Principal Display Panel (50 Pouch Box)

Principal Display Panel (50 Pouch Box)

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