Quality Choice 44-226-delisted

Quality Choice 44-226-delisted
SPL v14
SPL
SPL Set ID 5a75ff5b-78d5-4ab4-b648-f1a9511efd30
Route
ORAL
Published
Effective Date 2025-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Aluminum Lake Dextrose Monohydrate Dibasic Calcium Phosphate Dihydrate Fd&c Yellow No. 6 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;226 Shape: round Color: yellow Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 1996-11-21 Until 2027-09-30

Description

Caffeine 200 mg 

Purpose

Alertness aid 


Medication Information

Purpose

Alertness aid 

Description

Caffeine 200 mg 

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness 

Warnings

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. 

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

Do Not Use
  • for children under 12 years of age

  • as a substitute for sleep 
Other Information
  • each tablet contains: calcium 35 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dextrates hydrated, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

1-800-426-9391 

Principal Display Panel

NDC 63868-114-16

QC®

QUALITY

CHOICE

*Compare to the

Active ingredient in 

VIVARIN®

Stay Awake

Caffeine 200 mg

Alertness Aid

Equal to About a Cup of Coffee

actual

size

16 Tablets

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed

by Meda AB, owner of the registered trademark

Vivarin®.   50844        REV1219B22621

SATISFACTION

GUARANTEED

100%

QC

Distributed by C.D.M.A., Inc©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions:800-935-2362

Quality Choice 44-226


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 right away. 

Active Ingredient (in Each Tablet)

Caffeine 200 mg 


Structured Label Content

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness 

Purpose

Alertness aid 

Warnings

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. 

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

Do Not Use (Do not use)
  • for children under 12 years of age

  • as a substitute for sleep 
Other Information (Other information)
  • each tablet contains: calcium 35 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, dextrates hydrated, dibasic calcium phosphate dihydrate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments? (Questions or comments?)

1-800-426-9391 

Principal Display Panel

NDC 63868-114-16

QC®

QUALITY

CHOICE

*Compare to the

Active ingredient in 

VIVARIN®

Stay Awake

Caffeine 200 mg

Alertness Aid

Equal to About a Cup of Coffee

actual

size

16 Tablets

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed

by Meda AB, owner of the registered trademark

Vivarin®.   50844        REV1219B22621

SATISFACTION

GUARANTEED

100%

QC

Distributed by C.D.M.A., Inc©

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Questions:800-935-2362

Quality Choice 44-226


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 right away. 

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Caffeine 200 mg 


Advanced Ingredient Data


Raw Label Data

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