OTC Medication Information: Stay Awake

STAY AWAKE- caffeine tablet
H E B

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.

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

stay awake image
(click image for full-size original)
STAY AWAKE
caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-409
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAFFEINE (CAFFEINE) CAFFEINE 200 mg
Inactive Ingredients
Ingredient Name Strength
DEXTROSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
MALTODEXTRIN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11mm
Flavor Imprint Code L409
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37808-409-73 16 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (37808-409-73)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part340 03/25/1996
Labeler — H E B (007924756)

Revised: 11/2017 H E B

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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