FDA.reportPublic FDA data

Caffeine

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:35:31

Label at a glance#

ProductCaffeine
Active ingredientCAFFEINE
Label structure10 sections

Indications and uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Dosage and administration

■ adults and children 12 years of age and over: take 1 tablet not more often than every 4 hours

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Caffeine 200 mg

OTC - PURPOSE SECTION

Purpose

Alertness aid

Uses

INDICATIONS & USAGE SECTION

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

■as a substitute for sleep. This product is intended for occasional use only

■in children under 12 years of age

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years of age and over: take 1 tablet not more often than every 4 hours

Other information

OTHER SAFETY INFORMATION

■ each tablet contains: calcium 60 mg

■ Store in a dry place at 15°-30°C (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Vespyr Brands LLC, owner of the registered trademark Vivarin®.

DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com 1-800-200-6313

©2024 Cardinal Health. All other marks are the property of their respective owners.

100% Money Back Guarantee

Return to place of purchase.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader

NDC 70000-0409-1

Caffeine Tablets

Caffeine, 200mg/ Alertness Aid

For Mental Alertness

Safe & Effective

COMPARE TO VIVARIN® active ingredient*

100% Money Back Guarantee

16 Tablets

Leader labelLeader label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198520caffeine 200 MG Oral TabletPSN6
198520caffeine 200 MG Oral TabletSCD6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295135251GTIN-13: 0096295135251
EAN-13: 0096295135251
GTIN-12: 096295135251
UPC-A: 096295135251
GTIN storage (14 digits): 00096295135251		5009-16BB-Leader-G1_IFC R53565.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
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0409-1Caffeine8 in 1 BLISTER PACKTABLET86
70000-0409-1Caffeine2 in 1 CARTONTABLET26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0409-1EA - Each70000-0409f5706bc3-c51d-4bdd-b47a-5548eeeff0b712019-11-12

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-040970000-0409-1

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
CAFFEINE3G6A5W338EACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
MAGNESIUM STEARATE70097M6I30IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-10-27monthly-update2026-06-03 17:38:04
42024-01-23full-release2026-06-01 00:07:45

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
CaffeineCAFFEINELEADER/ Cardinal Health 110, Inc.7c4d61f7-9c6a-61ac-e053-2991aa0a95332026-01-28WarningsExact identifier
ndc (package): 70000-0409-1
ndc (product): 70000-0409
ndc11 (package): 70000040901
spl id: 497945c6-ed39-4111-e063-6394a90a3cf3
spl set id: 7c4d61f7-9c6a-61ac-e053-2991aa0a9533

Reported adverse events (FAERS/openFDA)#

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