Stay Awake

Manufacturer
SMART SENSE (KMART)
Effective date
2021-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:26:26

Label at a glance#

ProductStay Awake
Active ingredientCAFFEINE
Label structure9 sections

Dosage and administration

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

Storage and handling

each tablet contains: calcium 80 mg store between 20-25°C (68-77°F) retain carton for complete product information and warnings

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Caffeine 200 mg

Purpose

OTC - PURPOSE SECTION

Alertness aid

Use

INDICATIONS & USAGE SECTION

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For occasional use only

Do not use

  • in children under 12 years of age
  • as a substitute for sleep

OTC - WHEN USING SECTION

When using this product 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. The recommended dose of this product contains about as much caffeine as a cup of coffee.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 80 mg
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information and warnings

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smart sense

NDC 49738-020-02

COMPARE TO THE ACTIVE INGREDIENT OF VIVARIN(R) TABLETS

MAXIMUM STRENGTH

stay awake

ACTUAL SIZE

CAFFEINE - ALERTNESS AID

40 TABLETS - 200 mg EACH

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49738-02049738-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

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
d1563327-b733-4132-e053-2a95a90a223bd83ace81-e535-4393-a186-3bf4f413b2dc2021-11-21WarningsExact identifier
spl id: d1563327-b733-4132-e053-2a95a90a223b
spl set id: d83ace81-e535-4393-a186-3bf4f413b2dc

Reported adverse events (FAERS/openFDA)#

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