Premier Value 44-112-delisted

Premier Value 44-112-delisted
SPL v14
SPL
SPL Set ID 270e9221-d305-4148-b523-741e02fe733f
Route
ORAL
Published
Effective Date 2025-07-18
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 Completed Since 1981-08-25 Until 2027-08-31

Description

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant


Medication Information

Purpose

Nasal decongestant

Description

Pseudoephedrine HCl 30 mg

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
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

Premier

Value®

*COMPARE TO THE ACTIVE INGREDIENT IN

SUDAFED® SINUS CONGESTION

Maximum Strength

Nasal Decongestant

Pseudoephedrine HCl 30 mg

Nasal Decongestant

Non-Drowsy

• Nasal & Sinus Congestion

• Sinus Pressure

96 Tablets

actual

size

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN,

BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Sudafed® Sinus Congestion.

 50844      REV0619A11246

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

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
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland

Structured Label Content

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves sinus congestion and pressure
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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
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

Premier

Value®

*COMPARE TO THE ACTIVE INGREDIENT IN

SUDAFED® SINUS CONGESTION

Maximum Strength

Nasal Decongestant

Pseudoephedrine HCl 30 mg

Nasal Decongestant

Non-Drowsy

• Nasal & Sinus Congestion

• Sinus Pressure

96 Tablets

actual

size

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS

OPENED OR IF BLISTER UNIT IS TORN,

BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson

Corporation, owner of the registered trademark Sudafed® Sinus Congestion.

 50844      REV0619A11246

Distributed By:

Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

PV

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

If for any reason you are not satisfied with

this product, please return it to the store

where purchased for a full refund.

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
  • high blood pressure
  • thyroid disease
  • difficulty in urination due to enlargement of the prostate gland

Advanced Ingredient Data


Raw Label Data

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