Checked
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 form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 200 mg | oral | 1 |
| Tablet, film coated | 200 mg | oral | 1 |
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
- Class IIDrugOngoing11/12/2025Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count...Aero Healthcare · Labeling: Label Mix-up. This issue affects the outer box labeling...
- Class IDrugOngoing08/28/2024Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count...Aurobindo Pharma USA Inc · Labeling: Missing Label - some bottles are missing the the...
- Class IIIDrug10/05/2022oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert...QuVa Pharma, Inc. · Incorrect Product Formulation: Oxytocin 30 units was added to an...
- Class IIDrugOngoing08/31/2022JET ALERT TABLET 30 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.Family Dollar Stores, Llc. · CGMP Deviations: product held outside appropriate storage...
- Class IIDrug02/16/2022HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container...ULTRAtab Laboratories, Inc. · 4 products · CGMP Deviations
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