Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Caffeine 200 mg
OTC - PURPOSE SECTION
Purpose Alertness aid
343R- ALERT
- Set ID
- d221f66d-06bb-44e8-a01b-f5919f5c52d2
- Manufacturer
- Time Cap Labs, Inc
- Effective date
- 2018-12-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:57:44
Key Label Information
Uses
INDICATIONS & USAGE SECTION
Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
Warnings
WARNINGS SECTION
Warnings For occasional use only
OTC - DO NOT USE SECTION
Do not use in children under 12 years of age as a substitute for sleep
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours
Other Label Information
STORAGE AND HANDLING SECTION
Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) avoid excessive heat (greater than 100°F) or humidity use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba 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
Products
- Alert
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| DEXTRATES | G263MI44RU | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| HYPROMELLOSE 2910 (6 MPA.S) | 0WZ8WG20P6 | IACT |
| HYPROMELLOSE 2910 (15 MPA.S) | 36SFW2JZ0W | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POLYETHYLENE GLYCOL 8000 | Q662QK8M3B | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| CAFFEINE | 3G6A5W338E | ACTIB |
Complete SPL Sections
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet) Caffeine 200 mg
OTC - PURPOSE SECTION
Purpose Alertness aid
INDICATIONS & USAGE SECTION
Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
WARNINGS SECTION
Warnings For occasional use only
OTC - DO NOT USE SECTION
Do not use in children under 12 years of age as a substitute for sleep
OTHER SAFETY INFORMATION
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 heartbeat.
OTC - STOP USE SECTION
Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours
STORAGE AND HANDLING SECTION
Other information store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F) avoid excessive heat (greater than 100°F) or humidity use by expiration date on package
INACTIVE INGREDIENT SECTION
Inactive ingredients carnauba 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
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/d221f66d-06bb-44e8-a01b-f5919f5c52d2/7d3e5e3c-3199-5637-e053-2991aa0a0d27.xml
- XML SHA-256
- 31ed49776ddd7c6fb7974920e5d83bb82ef0ad9ad08794363116501eeb474254
- XML bytes
- 27257
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 343R.jpg | 2018-12-18 |
| otc | 7d3e5e3c-3199-5637-e053-2991aa0a0d27.xml | 2018-12-18 |