MedPath

Nasal Decongestant

Good Neighbor Pharmacy 44-112

Approved
Approval ID

1fdb1ba5-4072-4baf-9e30-f01d57bf6d82

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 13, 2025

Manufacturers
FDA

Amerisource Bergen

DUNS: 007914906

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Pseudoephedrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46122-428
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pseudoephedrine HCl
Product Specifications
Route of AdministrationORAL
Effective DateAugust 13, 2025
FDA Product Classification

INGREDIENTS (13)

PSEUDOEPHEDRINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 6V9V2RYJ8N
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/13/2025

Principal display panel

GOOD
** NEIGHBOR**
** PHARMACY®**

Compare to Sudafed® Sinus
** Congestion active ingredient***

NDC 46122-428-61

MAXIMUM STRENGTH

Nasal Decongestant
** pseudoephedrine hydrochloride**
****(nasal decongestant)

Non-Drowsy/Pseudoephedrine HCl

Relief of:
** • Nasal & Sinus Congestion**
** • Sinus Pressure**

96Tablets | 30 mg Each

Actual Size

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 Kenvue Inc., owner of the registered trademark
Sudafed® Sinus Congestion.
50844 ORG061911246

Distributed By
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?
www.mygnp.com

![Good neighbor pharmacy 44-112](/dailymed/image.cfm?name=good-neighbor- pharmacy-44-112-1.jpg&id=892552)

Good neighbor pharmacy 44-112

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/13/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/13/2025

Active ingredient (in each tablet)

Pseudoephedrine HCl 30 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/13/2025

Purpose

Nasal decongestant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2025

Warnings

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.

Ask a doctor before use if you have

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

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2025

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

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 8/13/2025

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)
  • see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/13/2025

Questions or comments?

1-800-426-9391

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