Major 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

Medication Information

Purpose

Antihistamine

Description

Chlorpheniramine maleate 4 mg

Uses

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

runny nose
itchy, watery eyes
sneezing
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

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

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

NDC 0904-0012-59

MAJOR®

4 hour

allergy tablets

chlorpheniramine maleate 4 mg

antihistamine

relieves: sneezing, runny nose, itchy, watery eyes, itchy throat

actual size

100 tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0419P19412

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Rev. 06/25 M-17 Re-order No. 700459

Major 44-194

When Using This Product

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

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

Principal Display Panel Unit Dose

NDC 0904-0012-61

MAJOR®

Unit Dose

ALLERGY TABLETS

CHLORPHENIRAMINE MALEATE

Antihistamine

4 mg each

Institutional Dispensing Only

100 TABLETS

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

50844 REV0419D19412

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Rev. 08/24 M-17 Re-order No. 301560

Major 44-194-DSP

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:

runny nose
itchy, watery eyes
sneezing
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)

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

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

NDC 0904-0012-59

MAJOR®

4 hour

allergy tablets

chlorpheniramine maleate 4 mg

antihistamine

relieves: sneezing, runny nose, itchy, watery eyes, itchy throat

actual size

100 tablets

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0419P19412

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

Rev. 06/25 M-17 Re-order No. 700459

Major 44-194

When Using This Product (When using this product)

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

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

Principal Display Panel Unit Dose (Principal Display Panel - Unit Dose)

NDC 0904-0012-61

MAJOR®

Unit Dose

ALLERGY TABLETS

CHLORPHENIRAMINE MALEATE

Antihistamine

4 mg each

Institutional Dispensing Only

100 TABLETS

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

50844 REV0419D19412

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Rev. 08/24 M-17 Re-order No. 301560

Major 44-194-DSP

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: runny nose itchy, watery eyes sneezing 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": "see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) protect from excessive moisture", "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": "NDC 0904-0012-59 MAJOR® 4 hour allergy tablets chlorpheniramine maleate 4 mg antihistamine relieves: sneezing, runny nose, itchy, watery eyes, itchy throat actual size 100 tablets TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 50844 REV0419P19412 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Rev. 06/25 M-17 Re-order No. 700459 Major 44-194", "When using this product": "drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery 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": "a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland", "Principal Display Panel - Unit Dose": "NDC 0904-0012-61 MAJOR® Unit Dose ALLERGY TABLETS CHLORPHENIRAMINE MALEATE Antihistamine 4 mg each Institutional Dispensing Only 100 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING 50844 REV0419D19412 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com Rev. 08/24 M-17 Re-order No. 301560 Major 44-194-DSP", "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