5350-hartland

5350-hartland
SPL v1
SPL
SPL Set ID e8ba7003-9d0f-90ac-e053-2995a90aa7de
Route
ORAL
Published
Effective Date 2022-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (200 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Croscarmellose Sodium Microcrystalline Cellulose Starch, Corn Silicon Dioxide Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: 212;212 Shape: round Color: white Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-01-20

Description

Active ingredient (in each tablet) Caffeine 200 mg


Medication Information

Warnings and Precautions

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 heartbeat.

Description

Active ingredient (in each tablet) Caffeine 200 mg

Use

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

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by:

NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharmaco.com

1-800-383-0648

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by LIL' DRUG STORE PRODUCTS, INC., owner of the registered trademark Maximum Strength NoDoz®.

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 50570-1

Do not use

■ in children under 12 years of age

■ as substitute for sleep

Section 51727-6

corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

Section 51945-4

NDC 80136-855-26

Compare to active ingredient in Maximum Strength NoDoz ®*

Heartland Pharma Co.

Maximum Strength

Caffeine Tablets

Caffeine, 200 mg

Alertness Aid

60 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 1/2 to 1 tablet not more often than every 3 to 4 hours

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information

each tablet contains: calcium 65 mg

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

Questions Or Comments?



1-800-231-4670


Structured Label Content

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

Warnings and Precautions (34071-1)

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 heartbeat.

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)

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

Distributed by:

NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharmaco.com

1-800-383-0648

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by LIL' DRUG STORE PRODUCTS, INC., owner of the registered trademark Maximum Strength NoDoz®.

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 50570-1 (50570-1)

Do not use

■ in children under 12 years of age

■ as substitute for sleep

Section 51727-6 (51727-6)

corn starch, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silica

Section 51945-4 (51945-4)

NDC 80136-855-26

Compare to active ingredient in Maximum Strength NoDoz ®*

Heartland Pharma Co.

Maximum Strength

Caffeine Tablets

Caffeine, 200 mg

Alertness Aid

60 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 1/2 to 1 tablet not more often than every 3 to 4 hours

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Other Information (Other information)

each tablet contains: calcium 65 mg

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

Questions Or Comments? (Questions or comments?)



1-800-231-4670


Advanced Ingredient Data


Raw Label Data

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