FDA.reportPublic FDA data

ALERTNESS AID - Caffeine Tablets, 200 mg

Manufacturer
We Care Distributor Inc. | Time Cap Labs, Inc
Effective date
2016-03-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:45:25

Label at a glance#

ProductALERTNESS AID
Active ingredientCAFFEINE
Label structure9 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 or over: take 1 tablet not more often than every 3 to 4 hours

Storage and handling

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) ■ avoid excessive heat (greater than 100°F) or humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each tablet)                 Purpose

Caffeine 200 mg........................................Alertness aid

Uses

INDICATIONS & USAGE SECTION

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WARNINGS SECTION

For occasional use only

SPL UNCLASSIFIED SECTION

Do not use

■ in children under 12 years of age

■ as a substitute for sleep

Caffeine warning

SPL UNCLASSIFIED SECTION

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years of age or over: take 1 tablet not more often than every 3 to 4 hours

Other information

STORAGE AND HANDLING SECTION

■ store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)

■ avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, D&C yellow no10 aluminum lake, dextrates, FD&C yellow no 6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Vivarin®

ALERTNESS AID

Caffeine Tablets, 200 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Tablets Each

Principal Display Panel - 50 Pouch BoxPrincipal Display Panel - 50 Pouch Box

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-020-022020-01-31C16284748780-19d75b9cf-f2cf-f424-e053-dadaa90a57ceALERTNESS AID - Caffeine Tablets, 200 mg
70005-020-252020-01-31C16284748780-19d75b9cf-f2cf-f424-e053-dadaa90a57ceALERTNESS AID - Caffeine Tablets, 200 mg
70005-020-502020-01-31C16284748780-19d75b9cf-f2cf-f424-e053-dadaa90a57ceALERTNESS AID - Caffeine Tablets, 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-020-02ALERTNESS AID2 in 1 POUCHTABLET, COATED26
70005-020-25ALERTNESS AID2 in 1 POUCHTABLET, COATED26
70005-020-25ALERTNESS AID25 in 1 BOXTABLET, COATED256
70005-020-50ALERTNESS AID2 in 1 POUCHTABLET, COATED26
70005-020-50ALERTNESS AID50 in 1 BOXTABLET, COATED506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-020ALERTNESS AID (CAFFEINE TABLETS, 200 MG) TABLET, COATED [WE CARE DISTRIBUTOR INC.]6Legacy NDC, 5 package rows20160315_7d671a58-ecb9-4368-8f7f-0b965e49cbcb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70005-02070005-020-25, 70005-020-50, 70005-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
DEXTRATESG263MI44RUIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

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
cc191c28-7fdf-41b0-8c30-46e358af0caa7d671a58-ecb9-4368-8f7f-0b965e49cbcb2016-03-08WarningsExact identifier
spl id: cc191c28-7fdf-41b0-8c30-46e358af0caa
spl set id: 7d671a58-ecb9-4368-8f7f-0b965e49cbcb

Reported adverse events (FAERS/openFDA)#

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