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: AAA Pharmaceutical, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 14967dc9-d223-d954-e063-6394a90aa676
SPL ID: 1acb92f2-304e-30bb-e063-6394a90ac9e1
Version: 2
Effective date: 2024-06-13
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:53:20

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		AAA Pharmaceutical, Inc.	openfda.manufacturer_name
ndc	package	57344-220-02	openfda.package_ndc
ndc	product	57344-220	openfda.product_ndc
ndc11	package	57344022002	derived:openfda.package_ndc
rxcui		198520	openfda.rxcui
spl id		1acb92f2-304e-30bb-e063-6394a90ac9e1	id
spl set id		14967dc9-d223-d954-e063-6394a90aa676	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 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 fatigue or drowsiness persists or continues to recur If pregnant or breast-feeding, ask a health professional before use. 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).

Reported adverse events (FAERS/openFDA)#

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