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NDC 00363-0226-12 Stay Awake 200 mg/1 Details

Stay Awake 200 mg/1

Stay Awake is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. The primary component is CAFFEINE.

Product Information

NDC	00363-0226
Product ID	0363-0226_b8f5a0ba-07ca-4b3e-ba85-b8cd4814b223
Associated GPIs	61300010000320
GCN Sequence Number	000033
GCN Sequence Number Description	caffeine TABLET 200 MG ORAL
HIC3	A1B
HIC3 Description	XANTHINES
GCN	00212
HICL Sequence Number	000012
HICL Sequence Number Description	CAFFEINE
Brand/Generic	Generic
Proprietary Name	Stay Awake
Proprietary Name Suffix	Maximum Strength
Non-Proprietary Name	Caffeine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	CAFFEINE
Labeler Name	Walgreen Company
Pharmaceutical Class	Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part340
Listing Certified Through	n/a

Package

Package Images

NDC 00363-0226-12 (00363022612)

Pricing Information	N/A
NDC Package Code	0363-0226-12
Billing NDC	00363022612
Package	1 BOTTLE, PLASTIC in 1 CARTON (0363-0226-12) / 100 TABLET in 1 BOTTLE, PLASTIC
Marketing Start Date	1996-11-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 355a3268-c0c8-4bca-8d3b-3c90efb6bf5d Details

Active ingredient (in each tablet)

Caffeine 200 mg

Purpose

Alertness aid

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.

Do not use

for children under 12 years of age
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
children under 12 years: do not use

Other information

each tablet contains: calcium 35 mg
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

Walgreens

Compare to Vivarin® active ingredient††

NDC 0363-0226-12

Stay Awake

CAFFEINE 200 mg / ALERTNESS AID

MAXIMUM STRENGTH

• Caffeine for mental alertness

• Equal to about a cup of coffee

100 TABLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

††This product is not manufactured or distributed by Meda AB, owner of the registered trademark Vivarin®.

50844 REV1219A22612

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2018 Walgreen Co.

44-226

INGREDIENTS AND APPEARANCE

STAY AWAKE MAXIMUM STRENGTH

caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0226
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	44;226
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-0226-12	1 in 1 CARTON	11/21/1996	12/21/2023
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0363-0226-21	2 in 1 CARTON	11/21/1996	07/08/2018
2		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC:0363-0226-10	5 in 1 CARTON	11/21/1996	02/25/2023
3		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC:0363-0226-08	3 in 1 CARTON	11/21/1996	08/14/2021
4		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part340	11/21/1996	12/21/2023

Labeler - Walgreen Company (008965063)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(0363-0226)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	pack(0363-0226)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(0363-0226)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	pack(0363-0226)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(0363-0226)

Revised: 6/2022

Document Id: b8f5a0ba-07ca-4b3e-ba85-b8cd4814b223

Set id: 355a3268-c0c8-4bca-8d3b-3c90efb6bf5d

Version: 18

Effective Time: 20220603