Stay Awake

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:42:37

Label at a glance#

ProductStay Awake
Active ingredientCAFFEINE
Label structure14 sections

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)                                                                  
Caffeine 200 mg

Purpose

OTC - PURPOSE SECTION

Alertness Aid

INDICATIONS & USAGE SECTION

Use

■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

WARNINGS SECTION

Warnings

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 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.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

■ store at room temperature
■ avoid excessive heat (greater than 100°F) or humidity

INACTIVE INGREDIENT SECTION

carnauba wax*,croscarmellose sodium, colloidal silicon
dioxide*, dextrates*, D&C yellow #10 aluminum lake,
dicalcium phosphate*, FD&C red#40 lake*, FD&C yellow
#6 aluminum lake*, hypromellose, lactose*, magnesium
stearate, microcrystalline cellulose, polyethylene glycol,
silicon dioxide*, titanium dioxide
*contains one or more of these ingredients

OTC - QUESTIONS SECTION

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stay Awake

Caffeine 200 mg - alertness aid

safe and effective


20 Tablets


Display panelDisplay panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198520caffeine 200 MG Oral TabletPSN5
198520caffeine 200 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4151-2Stay Awake1 in 1 CARTONTABLET15
68210-4151-2Stay Awake20 in 1 BOTTLETABLET205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4151STAY AWAKE (CAFFEINE 200 MG TABLETS) TABLET [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 2 package rows20241213_e2ccb6c1-bb77-4692-b96d-9eb2bec52f37.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-415168210-4151-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
2901289e-f47e-4b90-e063-6394a90a8bcbe2ccb6c1-bb77-4692-b96d-9eb2bec52f372024-12-11WarningsExact identifier
spl id: 2901289e-f47e-4b90-e063-6394a90a8bcb
spl set id: e2ccb6c1-bb77-4692-b96d-9eb2bec52f37

Reported adverse events (FAERS/openFDA)#

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