Major 44-111

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg) Pseudoephedrine (60 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;111 Shape: round Color: white Size: 7 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 1992-12-16 Until 2023-01-31

Medication Information

Purpose

Antihistamine

Nasal decongestant

Description

Chlorpheniramine maleate 4 mg Pseudoephedrine HCl 60 mg

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- nasal congestion
- sneezing
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- sinus congestion and pressure

Directions

adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years: do not use

Do Not Use

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
store in a dry place and protect from light
see end flap for expiration date and lot number

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

MAJOR^®

NDC 0904-5351-24

Maximum Strength

SudoGest Sinus & Allergy

chlorpheniramine maleate 4 mg

antihistamine

pseudoephedrine HCl 60 mg

nasal decongestant

relieves: • runny nose sneezing itchy, watery eyes

sinus congestion and pressure

24 Tablets

Actual Size

50844 REV0619M11108

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Major 44-111

When Using This Product

do not exceed recommended dosage
drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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 Ingredients (in Each Tablet)

Chlorpheniramine maleate 4 mg

Pseudoephedrine HCl 60 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
heart disease
high blood pressure
diabetes
glaucoma
thyroid disease
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 (allergic rhinitis) or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- nasal congestion
- sneezing
- itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- sinus congestion and pressure

Purpose

Antihistamine

Nasal decongestant

Directions

adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
children under 12 years: do not use

Do Not Use (Do not use)

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Other Information (Other information)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
store in a dry place and protect from light
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

MAJOR^®

NDC 0904-5351-24

Maximum Strength

SudoGest Sinus & Allergy

chlorpheniramine maleate 4 mg

antihistamine

pseudoephedrine HCl 60 mg

nasal decongestant

relieves: • runny nose sneezing itchy, watery eyes

sinus congestion and pressure

24 Tablets

Actual Size

50844 REV0619M11108

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.major-rugby.com

TAMPER EVIDENT: DO NOT USE IF

PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS

ANY SIGNS OF TAMPERING

Major 44-111

When Using This Product (When using this product)

do not exceed recommended dosage
drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

nervousness, dizziness, or sleeplessness occur
symptoms do not improve within 7 days or occur with a fever

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 Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Chlorpheniramine maleate 4 mg

Pseudoephedrine HCl 60 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
heart disease
high blood pressure
diabetes
glaucoma
thyroid disease
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": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "60", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "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": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: runny nose itchy, watery eyes nasal congestion sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing sinus congestion and pressure", "Purpose": "Antihistamine Nasal decongestant", "Directions": "adults and children 12 years and over: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours. children under 12 years: do not use", "Do not use": "if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.", "Other information": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) store in a dry place and protect from light see end flap for expiration date and lot number", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "MAJOR ® NDC 0904-5351-24 Maximum Strength SudoGest Sinus & Allergy chlorpheniramine maleate 4 mg antihistamine pseudoephedrine HCl 60 mg nasal decongestant relieves: • runny nose sneezing itchy, watery eyes sinus congestion and pressure 24 Tablets Actual Size 50844 REV0619M11108 Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Major 44-111", "When using this product": "do not exceed recommended dosage drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever", "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 ingredients (in each tablet)": "Chlorpheniramine maleate 4 mg Pseudoephedrine HCl 60 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis heart disease high blood pressure diabetes glaucoma thyroid disease 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