FDA.reportPublic FDA data

caffeine

Manufacturer
Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2024-09-20
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-06-01 00:38:17

Label at a glance#

Productcaffeine
Active ingredientCAFFEINE
Label structure13 sections

Dosage and administration

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

Storage and handling

each tablet contains calcium 60 mg store in a dry place at 15° - 30°C (59° - 86°F) avoid excessive heat (greater than 100°F) or humidity

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Caffeine 200mg


Purpose

OTC - PURPOSE SECTION

Alertness aid

Use

INDICATIONS & USAGE SECTION

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

WARNINGS SECTION

Do not use

  • as a substitute for sleep. This product is intended for occasional use only.
  • in children under 12 years of age

When using this product

OTC - WHEN USING SECTION

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.

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 (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 3 to 4 hours.

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains calcium 60 mg
  • store in a dry place at 15° - 30°C (59° - 86°F)
  • avoid excessive heat (greater than 100°F) or humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate dihydrate, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, corn starch, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-274-4122
Distributed by:
Aurohealth LLC.
279 Princeton-Hightstown Road,
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/16/2014

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (40 Tablets Blister Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH

NDC 58602-747-47

Compare to the active
ingredient in Vivarin®*

CAFFEINE TABLETS 200 mg
ALERTNESS AID

EQUAL TO ABOUT
A CUP OF COFFEE
40 Tablets/200 mg Each
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (16 Tablets Container Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (16 Tablets Container Carton)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198520caffeine 200 MG Oral TabletPSN1
198520caffeine 200 MG Oral TabletSCD1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-747-47caffeine5 in 1 CARTONTABLET51
58602-747-47caffeine8 in 1 BLISTER PACKTABLET81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-747CAFFEINE TABLET [AUROHEALTH LLC]1Current NDC, 2 package rows20241122_2dbf82e7-8f3a-47fb-8045-9136f4b9ae49.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-74758602-747-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAFFEINE3G6A5W338EACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
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
caffeineCAFFEINEAurohealth LLC2dbf82e7-8f3a-47fb-8045-9136f4b9ae492024-09-20WarningsExact identifier
ndc (package): 58602-747-47
ndc (product): 58602-747
ndc11 (package): 58602074747
spl id: 2dbf82e7-8f3a-47fb-8045-9136f4b9ae49
spl set id: 2dbf82e7-8f3a-47fb-8045-9136f4b9ae49

Reported adverse events (FAERS/openFDA)#

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