Quality Plus 44-226

Quality Plus 44-226

Drug Labeling and Warnings

Drug Details

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ALERT ALERTNESS AID- caffeine tablet 
L.N.K. International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Quality Plus 44-226

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

Uses

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 heartbeat.

Do not use

  • in children under 12 years
  • as a substitute for sleep

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.

Directions

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

Other information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

QUALITY
PLUS

NDC: 50844-226-21

*Compare to active ingredient
in VIVARIN®

ALERT TABLETS
Caffeine 200 mg

ALERTNESS AID

Equal to about a cup of coffee

16 Tablets

ACTUAL SIZE

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 Meda
Consumer Healthcare, owner of the registered trademark Vivarin®.
50844                 REV0412A22621

Distributed by LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

Quality Plus 44-226

Quality Plus 44-226

ALERT  ALERTNESS AID
caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50844-226
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE200 mg
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 44;226
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50844-226-212 in 1 CARTON11/21/1996
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34011/21/1996
Labeler - L.N.K. International, Inc. (038154464)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(50844-226)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(50844-226)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(50844-226)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(50844-226)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(50844-226)

Revised: 3/2019
 
L.N.K. International, Inc.


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