FDA.reportPublic FDA data

careone stay awake

Manufacturer
American Sales Company
Effective date
2019-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:31:15

Label at a glance#

Productcareone stay 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

• store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

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

For occasional use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

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.

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 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

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, pregelatinized starch

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Vivarin®

STAY AWAKE

Caffeine Tablets 200mg

Alertness Aid

Safe and Effective

Aids in Mental Alertness

OUR PHARMACISTS RECOMMEND

Actual Size

16 TABLETS

stay awake image
stay awake image

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-70841520-708-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
DEXTROSEIY9XDZ35W2IACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MALTODEXTRIN7CVR7L4A2DIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
1e584965-f3a7-478e-989b-c8d5e5094be85c92de1e-9494-42be-a0b8-0fbc673412092024-10-30WarningsExact identifier
spl set id: 5c92de1e-9494-42be-a0b8-0fbc67341209

Reported adverse events (FAERS/openFDA)#

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