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

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Directions

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

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

Description

Active ingredient (in each tablet) Caffeine 200 mg

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Questions Or Comments?

1-800-231-4670

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Uses

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Directions

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

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

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

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