SPL v1
SPL
SPL Set ID 2dbf82e7-8f3a-47fb-8045-9136f4b9ae49
Route
ORAL
Published
Effective Date 2024-09-20
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Yellow No. 6 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polysorbate 80 Starch, Corn Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: C5 Shape: round Color: yellow Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-04

Description

Active ingredient (in each tablet) Caffeine 200mg

Purpose

Alertness aid


Medication Information

Purpose

Alertness aid

Description

Active ingredient (in each tablet) Caffeine 200mg

Use

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

Do not use

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

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200mg



Other Information
  • 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

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?

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

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.

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 (1-800-222-1222) right away.

Package Label Principal Display Panel 200 Mg (40 Tablets Blister Carton)

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




Structured Label Content

Use

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Purpose

Alertness aid

Warnings

Do not use

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

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200mg



Other Information (Other information)
  • 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 ingredients)

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? (Questions or comments?)

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

When Using This Product (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.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

fatigue or drowsiness persists or continues to recur.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Package Label Principal Display Panel 200 Mg (40 Tablets Blister Carton) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 200 mg (40 Tablets Blister Carton))

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




Advanced Ingredient Data


Raw Label Data

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