Awake Maximum Strength

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: Awake Maximum Strength
Generic name: CAFFEINE
Manufacturer: Topco Associates, LLC
Product type: HUMAN OTC DRUG
SPL set ID: e8961b01-d692-40e7-a52f-2d81a21f06c5
SPL ID: 40e82efd-a4c9-4b38-965a-0178f507503d
Version: 10
Effective date: 2025-10-15
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:44:57

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		Awake Maximum Strength	openfda.brand_name
generic name		CAFFEINE	openfda.generic_name
manufacturer name		Topco Associates, LLC	openfda.manufacturer_name
ndc	package	36800-844-11	openfda.package_ndc
ndc	product	36800-844	openfda.product_ndc
ndc11	package	36800084411	derived:openfda.package_ndc
rxcui		198520	openfda.rxcui
spl id		40e82efd-a4c9-4b38-965a-0178f507503d	id
spl set id		e8961b01-d692-40e7-a52f-2d81a21f06c5	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 Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 heart beat. Do not use for children under 12 years of age as a substitute for sleep 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.

Reported adverse events (FAERS/openFDA)#

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