5009-cardinal

SPL v6

SPL

SPL Set ID 7c4d61f7-9c6a-61ac-e053-2991aa0a9533

Route

ORAL

Published

Effective Date 2026-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Caffeine (200 mg)

Inactive Ingredients

Croscarmellose Dibasic Calcium Phosphate Dihydrate D&c Yellow No. 10 Food Yellow 3 Free Acid Microcrystalline Cellulose Starch, Corn Magnesium Stearate Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 212;212 Shape: round Color: yellow Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-04-05

Description

Active ingredient (in each tablet) Caffeine 200 mg

Medication Information

Warnings and Precautions

Warnings

Description

Active ingredient (in each tablet) Caffeine 200 mg

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Section 34088-5

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

Section 42229-5

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

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

*This product is not manufactured or distributed by Vespyr Brands LLC, owner of the registered trademark Vivarin®.

DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com 1-800-200-6313

100% Money Back Guarantee

Return to place of purchase.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

Section 50567-7

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.

Section 50570-1

Do not use

■as a substitute for sleep. This product is intended for occasional use only

■in children under 12 years of age

Section 51945-4

Leader

NDC 70000-0409-1

Caffeine Tablets

Caffeine, 200mg/ Alertness Aid

For Mental Alertness

Safe & Effective

COMPARE TO VIVARIN® active ingredient*

100% Money Back Guarantee

16 Tablets

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Alertness aid

Directions

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information

■ each tablet contains: calcium 60 mg

■ Store in a dry place at 15°-30°C (59°-86°F).

Inactive Ingredients

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

Questions Or Comments?

1-800-231-4670

Structured Label Content

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings and Precautions (34071-1)

Warnings

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

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

*This product is not manufactured or distributed by Vespyr Brands LLC, owner of the registered trademark Vivarin®.

DIST. BY CAH, DUBLIN, OH 43017

www.myleader.com 1-800-200-6313

100% Money Back Guarantee

Return to place of purchase.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

Section 50567-7 (50567-7)

Section 50570-1 (50570-1)

Do not use

■as a substitute for sleep. This product is intended for occasional use only

■in children under 12 years of age

Section 51945-4 (51945-4)

Leader

NDC 70000-0409-1

Caffeine Tablets

Caffeine, 200mg/ Alertness Aid

For Mental Alertness

Safe & Effective

COMPARE TO VIVARIN® active ingredient*

100% Money Back Guarantee

16 Tablets

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Alertness aid

Directions

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information (Other information)

■ each tablet contains: calcium 60 mg

■ Store in a dry place at 15°-30°C (59°-86°F).

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica

Questions Or Comments? (Questions or comments?)

1-800-231-4670

Advanced Ingredient Data

[{"name": "CROSCARMELLOSE", "unii": "029TFK992N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAFFEINE", "unii": "3G6A5W338E", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FOOD YELLOW 3 FREE ACID", "unii": "G2B7JWK1GG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness", "34071-1": "Warnings", "34088-5": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "42229-5": "RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Vespyr Brands LLC, owner of the registered trademark Vivarin®. DIST. BY CAH, DUBLIN, OH 43017 www.myleader.com 1-800-200-6313 ©2024 Cardinal Health. All other marks are the property of their respective owners. 100% Money Back Guarantee Return to place of purchase.", "50565-1": "Keep out of reach of children.", "50566-9": "Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.", "50567-7": "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.", "50570-1": "Do not use ■as a substitute for sleep. This product is intended for occasional use only ■in children under 12 years of age", "51945-4": "Leader NDC 70000-0409-1 Caffeine Tablets Caffeine, 200mg/ Alertness Aid For Mental Alertness Safe & Effective COMPARE TO VIVARIN® active ingredient* 100% Money Back Guarantee 16 Tablets", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Alertness aid", "Directions": "■ adults and children 12 years of age and over: take 1 tablet not more often than every 4 hours", "Drug Facts": "Active ingredient (in each tablet) Caffeine 200 mg", "Other information": "■ each tablet contains: calcium 60 mg ■ Store in a dry place at 15°-30°C (59°-86°F).", "Inactive ingredients": "corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, dicalcium phosphate, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, silica", "Questions or comments?": "1-800-231-4670"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:43.581710 · Updated: 2026-03-14T23:12:39.597935