STAY AWAKE- caffeine tablet, coated

Stay Awake by

Drug Labeling and Warnings

Stay Awake by is a Otc medication manufactured, distributed, or labeled by Shield Pharmaceuticals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each liquid-filled capsule)

Caffeine 200 mg

Purpose

Alertness aid

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings

DO NOT USE

Do not use

• as a substitute for sleep. This product is intended for occasional use only.
• in children under 12 years of age

WHEN USING

When using this productlimit 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

Stop use and ask a doctorif fatigue or drowsiness persists or continues to recur.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding,ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

adults and children 12 years and over:

• take 1 tablet not more often than every 3 to 4 hours

Other information

• each tablet contains: calcium 60 mg
• store in a dry place at 15° – 30°C (59° – 86°F)
• do not use if imprinted seal under cap is broken or missing

Questions or comments?

1-800-373-6981 (toll-free)

Inactive ingredients

FD&C yellow # 6, magnesium stearate, maize starch, microcrystalline cellulose, povidone, stearic acid, Sodium Starch Glycolate, talc

SPL UNCLASSIFIED SECTION

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

PRINCIPAL DISPLAY PANEL

Stay Awake

Caffeine 200 mg/ Alertness Aid

• Caffeine for mental alertness
• Equal to about a cup of coffee

Carton

Label

INGREDIENTS AND APPEARANCE

STAY AWAKE 
caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83059-0008
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, POTATO (UNII: 8I089SAH3T)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	D4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83059-0008-1	1 in 1 CARTON	01/16/2024
1		15 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/16/2024

Labeler - Shield Pharmaceuticals Corp (118724924)