ALLERTNESS AID- caffeine tablet
Chain Drug Consortium

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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Drug Facts

Active ingredient

Caffeine 200 mg

Purpose

Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

For occasional use only

Do Not Use

in children under 12 years of age as a substitute for sleep

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 occur . For occasional use only.

If pregnancy or breast-feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center right away.

Directions

Adults and children 12 years of age and older: take 1 tablet not more often than every 3 to 4 hours
Children under 12 years of age: Do not use

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10, dicalcium phosphate dihydrate, FD&C yellow #6, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, propylene glycol, titanium dioxide, triacetin

Package/Label Principal Display Panel

$Z:\SPL-OTC Mono\PV\Allertness Aid\LB1320.jpg$

ALLERTNESS AID
caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-195
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	200 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-195-03	16 in 1 BOX; Type 0: Not a Combination Product	11/03/2014	10/01/2018
2	NDC:68016-195-11	40 in 1 BOX; Type 0: Not a Combination Product	11/03/2014	10/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	11/03/2014	10/01/2018

Labeler - Chain Drug Consortium (101668460)

Registrant - Chain Drug Consortium (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
A&Z Pharmaceutical, Inc.		926820705	label(68016-195) , manufacture(68016-195) , pack(68016-195) , relabel(68016-195) , repack(68016-195)

Revised: 10/2018

Document Id: 78e605e7-f0bd-6e01-e053-2a91aa0ac084

Set id: 1a70f46d-0a71-44a0-90a9-0d237955dae9

Version: 2

Effective Time: 20181023

Chain Drug Consortium