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OTC

Alert

caffeine · Alert is a central nervous system stimulant (over-the-counter) containing caffeine, made by 2 manufacturers.

Type
Over the counter
Drug class
Central Nervous System Stimulant
Route
Oral
Manufacturers
2

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Drug facts

Generic name
caffeine
Active ingredients
Caffeine
Dosage forms
Tablet, Tablet, film coated
Label holder
DOLGENCORP, LLC
FDA application
M011
Label updated
05/06/2026

Active ingredients

(in each tablet) Caffeine 200 mg

Purpose

Alertness aid

Uses

Helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

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

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.

Do not use

For children under 12 years of age as a substitute for sleep

Stop use and ask a doctor

Fatigue or drowsiness persists or continues to recur.

Pregnancy or breastfeeding

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.

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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number

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

Questions?

1-888-309-9030

Forms and strengths

From the FDA NDC Directory · 2 product codes

Dosage formStrengthRouteNDCs
Tablet200 mgoral1
Tablet, film coated200 mgoral1

Manufacturers and labels

2 FDA labels

  • DOLGENCORP, LLCShown hereM011 · Label 05/06/2026 · NDC 55910-226Full label
  • Time Cap Labs, Incpart340 · Label 12/17/2018 · NDC 49483-343Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Alert: common questions

What is Alert used for?
helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Is Alert a prescription drug?
No. Alert is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Alert?
Yes. Other FDA-listed products with the same active ingredients include Stay Awake, Caffeine, Stay Awake Maximum Strength, Uplift Chewable.
Who makes Alert?
2 manufacturers list Alert with the FDA, including DOLGENCORP, LLC, Time Cap Labs, Inc.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 05/06/2026 · Label text is shown as published by the manufacturer. Not medical advice