OTC Medication Information: Allertness Aid

ALLERTNESS AID — caffeine tablet
Select Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredients Caffeine 200mg

Alertness Aid

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

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

Warnings: 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.

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

KEEP OUT OF REACH OF CHILDREN.

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

MM1

Alertness Packet
(click image for full-size original)
ALLERTNESS AID caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-470
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 200 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
SILICON DIOXIDE
CARNAUBA WAX
POLYETHYLENE GLYCOL 300
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
DEXTRATES
Product Characteristics
Color white (snow white) Score no score
Shape ROUND (TCL363) Size 11mm
Flavor Imprint Code TCL363
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52904-470-02 2 TABLET (TABLET) in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 10/15/2012
Labeler — Select Corporation (053805599)
Registrant — Select Corporation (053805599)

Revised: 10/2012 Select Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.