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#
Contacts and useful links#
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (in each tablet)
Caffeine 200 mg
Purpose
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
Stay Awake
Caffeine 200 mg - alertness aid
safe and effective
20 Tablets
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-4151-2 | Stay Awake | 1 in 1 CARTON | TABLET | 1 | 5 | |
| 68210-4151-2 | Stay Awake | 20 in 1 BOTTLE | TABLET | 20 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-4151 | STAY AWAKE (CAFFEINE 200 MG TABLETS) TABLET [SPIRIT PHARMACEUTICALS LLC] | 5 | Legacy NDC, 2 package rows | 20241213_e2ccb6c1-bb77-4692-b96d-9eb2bec52f37.zip |
Products#
Every source-derived product name is available through these pages.
- Stay Awake
- Caffeine 200 mg Tablets
- CARNAUBA WAX
- CROSCARMELLOSE SODIUM
- SILICON DIOXIDE
- D&C YELLOW NO. 10 ALUMINUM LAKE
- DEXTRATES
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- LACTOSE MONOHYDRATE
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- TITANIUM DIOXIDE
- CAFFEINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-4151 | 68210-4151-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2901289e-f47e-4b90-e063-6394a90a8bcb | e2ccb6c1-bb77-4692-b96d-9eb2bec52f37 | 2024-12-11 | Warnings | 2901289e-f47e-4b90-e063-6394a90a8bcb e2ccb6c1-bb77-4692-b96d-9eb2bec52f37 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
