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.

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

Other Information

■ each tablet contains: calcium 65 mg

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

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

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)

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.

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

Other Information (Other information)

■ each tablet contains: calcium 65 mg

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

Use

helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

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

Drug Facts

Active ingredient (in each tablet)

Caffeine 200 mg

Questions Or Comments? (Questions or comments?)



1-800-231-4670


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)