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Stay Awake

Winco 44-226

Approved
Approval ID

e47c6a09-ba26-4ebf-b6fb-3cf7ab04dc35

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 23, 2025

Manufacturers
FDA

WinCo Foods, LLC

DUNS: 056098817

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Caffeine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67091-117
Application NumberM011
Product Classification
M
Marketing Category
C200263
G
Generic Name
Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 23, 2025
FDA Product Classification

INGREDIENTS (9)

CAFFEINEActive
Quantity: 200 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083G
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/23/2025

Principal Display Panel

WinCo®
FOODS

Stay
** Awake**

CAFFEINE 200 mg/ ALERTNESS AID

*Compare to the active ingredient in VIVARIN®

Equal to About a Cup of Coffee

16
Tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
** OR IF BLISTER UNIT IS TORN,**
** BROKEN OR SHOWS ANY SIGNS OF TAMPERING**

DISTRIBUTED BY:
****WINCO FOODS, LLC, BOISE, ID 83704

*This product is not manufactured or distributed by
Vespyr Brands, Inc., distributor of VIVARIN®.

50844 REV1219C22621 WF2008

Winco 44-226

Winco 44-226

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/23/2025

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/23/2025

Active ingredient (in each tablet)

Caffeine 200 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/23/2025

Purpose

Alertness aid

WARNINGS SECTION

LOINC: 34071-1Updated: 9/23/2025

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/23/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/23/2025

Other information

*each tablet contains: calcium 35 mg

*TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/23/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/23/2025

Questions?

Call1-800- 824-1706 Monday - Friday 9am - 4pm MST

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