FDA.reportPublic FDA data

TopCare 44-344

Manufacturer
Topco Associates, LLC | LNK International, Inc.
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-10-16 01:01:46

Label at a glance#

ProductAwake Maximum Strength
Active ingredientCAFFEINE
Label structure9 sections

Dosage and administration

adults and children 12 years and over: take ½ to 1 caplet not more often than every 3 to 4 hours children under 12 years: do not use

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Caffeine 200 mg

Purpose

OTC - PURPOSE SECTION

Alertness aid

Use

INDICATIONS & USAGE SECTION

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • for children under 12 years of age
  • as a substitute for sleep

Stop use and ask a doctor if

OTC - STOP USE SECTION

fatigue or drowsiness persists or continues to recur.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: take ½ to 1 caplet not more often than every 3 to 4 hours
  • children under 12 years: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

+TopCare®
health

NDC 36800-844-11

COMPARE TO MAXIMUM
STRENGTH NODOZ®
ACTIVE INGREDIENT*

MAXIMUM STRENGTH
Awake CAFFEINE, 200 mg
Alertness Aid

• Helps Restore Mental Alertness When
  Experiencing Fatigue

60 CAPLETS

actual size

TopCare 44-344
TopCare 44-344

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800414396GTIN-13: 0036800414396
EAN-13: 0036800414396
GTIN-12: 036800414396
UPC-A: 036800414396
GTIN storage (14 digits): 00036800414396		topcare-44-344-1.jpg
QR code linkQR Codetopbrnds.com/48zzx4topcare-44-344-1.jpg

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-84436800-844-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
STARCH, CORNO8232NY3SJIACT
DEXTROSE MONOHYDRATELX22YL083GIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-10-15full-release2026-06-01 01:39:14
92024-10-03full-release2026-06-01 00:22:38

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
Awake Maximum StrengthCAFFEINETopco Associates, LLCe8961b01-d692-40e7-a52f-2d81a21f06c52025-10-15WarningsExact identifier
ndc (package): 36800-844-11
ndc (product): 36800-844
ndc11 (package): 36800084411
spl set id: e8961b01-d692-40e7-a52f-2d81a21f06c5

Reported adverse events (FAERS/openFDA)#

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