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NDC 63187-0344-24 Nasal Decongestant 30 mg/1 Details

Nasal Decongestant 30 mg/1

Nasal Decongestant is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is PSEUDOEPHEDRINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Related Packages: 63187-0344-24
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	63187-0344
Product ID	63187-344_b408c71a-3bfa-44aa-ad01-9c4b6e6ff291
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nasal Decongestant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pseudoephedrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0344-24 (63187034424)

Pricing Information	N/A
NDC Package Code	63187-344-24
Billing NDC	63187034424
Package	1 BLISTER PACK in 1 CARTON (63187-344-24) / 24 TABLET in 1 BLISTER PACK
Marketing Start Date	2014-03-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4eab4344-d95e-4b19-a21e-9c8ad033863a Details

Active ingredient (in each tablet)

•: Pseudoephedrine HCl 30 mg

Purpose

•: Nasal Congestant

Use(s)

•: temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
•: temporarily restores freer breathing through the nose

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 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

•: diabetes
•: high blood pressure
•: heart disease
•: thyroid disease
•: trouble urinating due to an enlarged prostate gland

When using this product

•: do not use more than directed

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 (1-800-222-1222).

Directions

adults and children 12 years and older	take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours
children ages 6 to 12 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

Other information

•: store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

•: calcium sulfate, carnauba wax, croscarmellose sodium, FD&C red #40 lake, FD&C yellow #6 lake, gelatin, kaolin, lactose, magnesium silicate, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, silica, stearic acid, sugar and titanium dioxide

Questions or comments?

1-800-645-2158

Principal Display Panel

Rugby®

compare to Sudafed®

Decongestant active ingredient*

NDC 63187-344-24

Nasal Decongestant

pseudoephedrine HCl 30 mg

Temporarily relieves:

• nasal congestion due to cold & allergies withoout drowsiness

24 tablets, 30 mg each

TAMPER EVIDENT: SAFETY SEALED: DO NOT USE IF BLISTER SEAL IS BROKEN

Rev 04/13

R-29

DISTRIBUTED BY:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150

www.rugbylaboratories.com

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

NASAL DECONGESTANT

pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-344(NDC:0536-3607)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
KAOLIN (UNII: 24H4NWX5CO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM SILICATE (UNII: 9B9691B2N9)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)
ACER SACCHARUM POLLEN (UNII: V38QUQ7861)

Product Characteristics
Color	RED	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	1004
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-344-24	1 in 1 CARTON	03/03/2014
1		24 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	10/29/2012

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-344)

Revised: 1/2021

Document Id: b408c71a-3bfa-44aa-ad01-9c4b6e6ff291

Set id: 4eab4344-d95e-4b19-a21e-9c8ad033863a

Version: 4

Effective Time: 20210101