VALUMEDS MAXIMUM STRENGTH STAY AWAKE- caffeine 200 mg tablets tablet

Valumeds Maximum Strength Stay Awake by

Drug Labeling and Warnings

Valumeds Maximum Strength Stay Awake by is a Otc medication manufactured, distributed, or labeled by Spirit Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)                                                                  
Caffeine 200 mg

Purpose

Alertness Aid

INDICATIONS & USAGE

Use

■ helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

WARNINGS

Warnings

For occasional use only

Do not use

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

WHEN USING

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

Stop use and ask a doctor if 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.

OVERDOSAGE

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

DOSAGE & ADMINISTRATION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

■ store at room temperature
■ avoid excessive heat (greater than 100°F) or humidity

INACTIVE INGREDIENT

Carnuba wax, colloidal silicon dioxide, D&C yellow #10 aluminum lake, dextrates,
FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, titanium dioxide

QUESTIONS

Questions or comments?

1-888-333-9792

PRINCIPAL DISPLAY PANEL

VALUMEDS

Compare to active ingredient in Vivarin

STAY AWAKE
MAXIMUM STRENGTH

Caffeine 200 mg

safe and effective

250 tablets

This product is not manufactured or distributed by Meda Consumer Healthcare
Inc., owner of the registered trademark Vivarin.

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

Made in India

INGREDIENTS AND APPEARANCE

VALUMEDS MAXIMUM STRENGTH STAY AWAKE 
caffeine 200 mg tablets tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68210-0403
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
DEXTRATES (UNII: G263MI44RU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	1mm
Flavor		Imprint Code	AZ076
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68210-0403-1	250 in 1 BOTTLE; Type 0: Not a Combination Product	08/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part340	08/06/2019

Labeler - Spirit Pharmaceuticals LLC (179621011)

Establishment
Name	Address	ID/FEI	Business Operations
ELYSIUM PHARMACEUTICALS LIMITED		915664486	manufacture(68210-0403)