Stay Awake

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Stay Awake
Generic name: CAFFEINE
Manufacturer: Marc Glassman, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: fda5b0a8-2c85-4a8b-97ab-777682c816e2
SPL ID: d7ab9f11-858d-41fb-b64f-614a194703c2
Version: 7
Effective date: 2016-12-21
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:24:06

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M011	openfda.application_number
brand name		Stay Awake	openfda.brand_name
generic name		CAFFEINE	openfda.generic_name
manufacturer name		Marc Glassman, Inc.	openfda.manufacturer_name
ndc	package	68998-076-84	openfda.package_ndc
ndc	product	68998-076	openfda.product_ndc
ndc11	package	68998007684	derived:openfda.package_ndc
rxcui		198520	openfda.rxcui
spl id		d7ab9f11-858d-41fb-b64f-614a194703c2	id
spl set id		fda5b0a8-2c85-4a8b-97ab-777682c816e2	set_id
unii		3G6A5W338E	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For occasional use only. Do not use in children under 12 years of age as a substitute for sleep When using this product limit the use of caffeine- containing medications, foods or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and occasional 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 fatigue or drowsiness persists or continues to occur. Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Reported adverse events (FAERS/openFDA)#

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