Major 44-112-dsp

Major 44-112-dsp
SPL v11
SPL
SPL Set ID da95c643-7122-4025-977f-42205080e56b
Route
ORAL
Published
Effective Date 2026-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pseudoephedrine (30 mg)
Inactive Ingredients
Croscarmellose Sodium Dibasic Calcium Phosphate Dihydrate Fd&c Red No. 40 Aluminum Lake Fd&c Yellow No. 6 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;112 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-12

Description

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 30 mg

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Directions
adults and children 12 years and over take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 11 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 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
  • each tablet contains: calcium 15 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions Or Comments?

1-800-426-9391

Principal Display Panel

MAJOR®

NDC 0904-6990-61

Unit Dose

PSEUDOEPHEDRINE HCI

NASAL DECONGESTANT

30 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        REV0619C11212

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Rev. 03/23    M-17    Re-order No. 701183

Major 44-112
When Using This Product

do not exceed recommended dosage.

Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occur
  • symptoms do not improve within 7 days or occur with 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 Ingredient (in Each Tablet)

Pseudoephedrine HCl 30 mg

Ask A Doctor Before Use If You Have
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses
  • temporarily relieves sinus congestion and pressure
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
Purpose

Nasal decongestant

Directions
adults and children 12 years and over take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 11 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours
children under 6 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)
  • each tablet contains: calcium 15 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

MAJOR®

NDC 0904-6990-61

Unit Dose

PSEUDOEPHEDRINE HCI

NASAL DECONGESTANT

30 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        REV0619C11212

Distributed by:

MAJOR® PHARMACEUTICALS

Indianapolis, IN 46268

(800) 616-2471

www.majorpharmaceuticals.com

Rev. 03/23    M-17    Re-order No. 701183

Major 44-112
When Using This Product (When using this product)

do not exceed recommended dosage.

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

Pseudoephedrine HCl 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • diabetes
  • heart disease
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data


Raw Label Data

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