Leader 44-194

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg)

Inactive Ingredients

Starch, Corn D&c Yellow No. 10 Aluminum Lake Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 1992-12-19 Until 2025-06-30

Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine maleate 4 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

Directions

take every 4 to 6 hours, or as directed by a doctor

adults and children 12 years and over	1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years	1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years	do not use

Do Not Use

to make a child sleepy.

Other Information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from excessive moisture
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

1-800-426-9391

Principal Display Panel

LEADER™

NDC 70000-0160-2

4 Hour

Allergy Relief

Chlorpheniramine Maleate, 4 mg | Antihistamine

Relief of:

Sneezing, Runny Nose,

Itchy Throat, Itchy, Watery Eyes

100 TABLETS

Actual Size

100% Money

Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CIN 5294319 REV. 4/20

50844 REV0419A19412

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

Essential to Care™ since 1979

©2020 Cardinal Health. All Rights Reserved. CARDINAL

HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE,

LEADER, and the Leader LOGO are trademarks or

registered trademarks of Cardinal Health.

All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Leader 44-194

When Using This Product

drowsiness may occur
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Chlorpheniramine maleate 4 mg

Ask A Doctor Before Use If You Have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

Purpose

Antihistamine

Directions

take every 4 to 6 hours, or as directed by a doctor

adults and children 12 years and over	1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years	1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years	do not use

Do Not Use (Do not use)

to make a child sleepy.

Other Information (Other information)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
protect from excessive moisture
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel (Principal display panel)

LEADER™

NDC 70000-0160-2

4 Hour

Allergy Relief

Chlorpheniramine Maleate, 4 mg | Antihistamine

Relief of:

Sneezing, Runny Nose,

Itchy Throat, Itchy, Watery Eyes

100 TABLETS

Actual Size

100% Money

Back Guarantee

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

CIN 5294319 REV. 4/20

50844 REV0419A19412

CardinalHealth™

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

Essential to Care™ since 1979

All LEADER™ Brand Products Have A

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Leader 44-194

When Using This Product (When using this product)

drowsiness may occur
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Chlorpheniramine maleate 4 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use", "Do not use": "to make a child sleepy.", "Other information": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from excessive moisture see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose", "Questions or comments?": "1-800-426-9391", "Principal display panel": "LEADER ™ NDC 70000-0160-2 4 Hour Allergy Relief Chlorpheniramine Maleate, 4 mg | Antihistamine Relief of: Sneezing, Runny Nose, Itchy Throat, Itchy, Watery Eyes 100 TABLETS Actual Size 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING CIN 5294319 REV. 4/20 50844 REV0419A19412 Cardinal Health™ DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Essential to Care™ since 1979 ©2020 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health. All LEADER™ Brand Products Have A 100% Money Back Guarantee Return to place of purchase if not satisfied. Leader 44-194", "When using this product": "drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each tablet)": "Chlorpheniramine maleate 4 mg", "Ask a doctor before use if you have": "glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information