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NDC 37808-0409-73 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 H E B. The primary component is CAFFEINE.

Product Information

NDC	37808-0409
Product ID	37808-409_abb60da2-4384-4fd4-9236-4614de58233f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Stay Awake
Proprietary Name Suffix	n/a
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	H E B
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	2024-12-31

Package

Package Images

NDC 37808-0409-73 (37808040973)

Pricing Information	N/A
NDC Package Code	37808-409-73
Billing NDC	37808040973
Package	16 BLISTER PACK in 1 CARTON (37808-409-73) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	1996-03-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 28d25382-e40f-479d-a6de-ce68bec9cc26 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

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 while taking this product 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 two cups 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 right away (1-800-222-1222).

Directions

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

Other information

•: store at 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrose, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, pregelatinized starch

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to Vivarin® Tablets active ingredient

Stay Awake

Caffeine, 200 mg

Alertness Aid

Safe and effective

actual size

16 TABLETS

INGREDIENTS AND APPEARANCE

STAY AWAKE

caffeine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37808-409
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
DEXTROSE (UNII: IY9XDZ35W2)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	L409
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37808-409-73	16 in 1 CARTON	03/25/1996
1		1 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	03/25/1996

Labeler - H E B (007924756)

Revised: 11/2017

Document Id: abb60da2-4384-4fd4-9236-4614de58233f

Set id: 28d25382-e40f-479d-a6de-ce68bec9cc26

Version: 3

Effective Time: 20171106