FDA.reportPublic FDA data

Alertness Aid Stay Awake

Manufacturer
Healthlife of USA | Time Cap Laboratories, Inc.
Effective date
2017-06-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:15:50

Label at a glance#

ProductAlertness Aid Stay Awake
Active ingredientCAFFEINE
Label structure12 sections

Indications and uses

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage and administration

Adults and children 12 years and over: Take 1 Tablet not more than every 3 to 4 hours

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Alertness Aid

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Caffeine 200mg

Uses

INDICATIONS & USAGE SECTION

  • Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WARNINGS SECTION

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 heartbeat.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

fatigue or drowsiness persists or continues to recur

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In c ase of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over: Take 1 Tablet not more than every 3 to 4 hours

Other Information 

OTC - QUESTIONS SECTION

  • Store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) or humidity
  • Avoid excessive heat (greater than 100°F) or  humidity
  • Read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • Carnauba wax
  • Colloidal silicon dioxide 
  • D&C yellow #10 aluminium lake
  • Dextrates
  • FD&C yellow#6 aluminium lake
  • Hypeomellose
  • Magnesium stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Titanium dioxide

Questions or comments? 

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com

Alertness Aid Stay Awake Caffeine 200mg / alertness AidSafe & Effective Helps Restore Alertness  Compare to Vivarin® active ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Distributed by:
Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69517-132-162024-06-13C16284748780-19d75b9d1-0609-f424-e053-dadaa90a57ceAlertness Aid Stay Awake
69517-132-162020-01-31C16284748780-19d75b9d1-0609-f424-e053-dadaa90a57ceAlertness Aid Stay Awake

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-13269517-132-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTRATESG263MI44RUIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOLS3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1ac7df61-9ba0-c872-e063-6294a90af0d997054376-4b20-459c-8799-920516e2897e2024-06-13WarningsExact identifier
spl set id: 97054376-4b20-459c-8799-920516e2897e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.