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NDC 11822-0650-06 sinus pressure and congestion relief 120 mg/1 Details

sinus pressure and congestion relief 120 mg/1

sinus pressure and congestion relief is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid Corporation. 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: 11822-0650-06
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine

Product Information

NDC	11822-0650
Product ID	11822-0650_fd0c9dad-76a4-411b-b358-2bfd3c181159
Associated GPIs	90750030000910 80303093600130 89994002335220
GCN Sequence Number	005777
GCN Sequence Number Description	salicylic acid CLEANSER 2 % TOPICAL
HIC3	L5A
HIC3 Description	KERATOLYTICS
GCN	22770
HICL Sequence Number	002465
HICL Sequence Number Description	SALICYLIC ACID
Brand/Generic	Generic
Proprietary Name	sinus pressure and congestion relief
Proprietary Name Suffix	maximum strength
Non-Proprietary Name	Pseudoephedrine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, FILM COATED, EXTENDED RELEASE
Route	ORAL
Active Ingredient Strength	120
Active Ingredient Units	mg/1
Substance Name	PSEUDOEPHEDRINE HYDROCHLORIDE
Labeler Name	Rite Aid Corporation
Pharmaceutical Class	Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA075153
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11822-0650-06 (11822065006)

Pricing Information	N/A
NDC Package Code	11822-0650-6
Billing NDC	11822065006
Package	20 BLISTER PACK in 1 CARTON (11822-0650-6) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date	2002-08-13
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa52d998-cab8-439c-ac95-6c1f5da48ba4 Details

Active ingredient (in each tablet)

Pseudoephedrine HCl 120 mg

Purpose

Nasal decongestant

Uses

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

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

•: heart disease
•: high blood pressure
•: thyroid disease
•: diabetes
•: trouble urinating due to an enlarged 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 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 (1-800-222-1222).

Directions

adults and children 12 years and over	• take 1 tablet every 12 hours • do not take more than 2 tablets in 24 hours
children under 12 years	do not use this product in children under 12 years of age

Other information

•: each tablet contains: calcium 45 mg
•: store at 20-25°C (68-77°F) in a dry place
•: protect from light
•: do not use if blister unit is broken or torn
•: see carton end panel for lot number and expiration date
•: this product meets the requirements of USP Drug Release Test 3

Inactive ingredients

carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

FREE FROM | GLUTEN FREE

12 HOUR

Compare to the active ingredient of Sudafed® Sinus Congestion 12 Hour

MAXIMUM STRENGTH

SINUS PRESSURE & CONGESTION RELIEF

PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 120 mg

NASAL DECONGESTANT

ACTUAL SIZE

Sinus Pressure + Congestion

NON-DROWSY

20 COATED CAPLETS** 120 mg EACH

**CAPSULE-SHAPED TABLETS

INGREDIENTS AND APPEARANCE

SINUS PRESSURE AND CONGESTION RELIEF MAXIMUM STRENGTH

pseudoephedrine hcl tablet, film coated, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0650
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	L054
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0650-6	20 in 1 CARTON	08/13/2002
1		1 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
ANDA	ANDA075153	08/30/1999

Labeler - Rite Aid Corporation (014578892)

Revised: 8/2022

Document Id: fd0c9dad-76a4-411b-b358-2bfd3c181159

Set id: aa52d998-cab8-439c-ac95-6c1f5da48ba4

Version: 4

Effective Time: 20220804