Nexafed

Manufacturer: Acura Pharmaceuticals, Inc. | Patheon Pharmaceuticals, Inc.
Effective date: 2020-07-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 23:21:30

Label at a glance#

ProductNexafed

Active ingredientPSEUDOEPHEDRINE HYDROCHLORIDE

Label structure12 sections

Indications and uses

for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Dosage and administration

take every 4 to 6 hours do not exceed 4 doses in 24 hours take tablets with enough water to ensure complete swallowing immediately after placing in the mouth adults and children 12 years and over 2 tablets children 6 years to under 12 years 1 tablet children under 6 years ask a doctor

Storage and handling

store at controlled room temperature 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Contacts and useful links#

PhoneLabel contact1-855-228-7201

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Pseudoephedrine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies
helps decongest sinus openings and passages; temporarily relieves sinus congestion and pressure

Warnings

WARNINGS SECTION

Do not exceed recommended dosage

If nervousness, dizziness or sleeplessness occurs, discontinue use and consult a doctor.

If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

OTC - DO NOT USE SECTION

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 contains an MAOI, ask a doctor or pharmacist before taking this product.

Do not take this product if you have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to the enlargement of the prostate gland unless directed by a doctor

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours
do not exceed 4 doses in 24 hours
take tablets with enough water to ensure complete swallowing immediately after placing in the mouth

adults and children 12 years and over	2 tablets
children 6 years to under 12 years	1 tablet
children under 6 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

INACTIVE INGREDIENT SECTION

Inactive ingredients colloid silicon dioxide, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and polyethylene oxide.

SPL UNCLASSIFIED SECTION

Questions or comments?

Please call 1-855-228-7201

DO NOT USE IF BLISTER UNIT IS BROKEN OR TORN

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartonnexafed^®

PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

NASAL DECONGESTANT

Battle congestion. And meth abuse too.

JOIN THE FIGHT.

With meth-deterring Impede ^™ technology
Maximum strength, non-drowsy formulation
Relieves nasal and sinus congestion

MANUFACTURED FOR:

MainPointe Pharmaceuticals, LLC

Louisville, KY 40202

US Patent Number 10,400,699

NDC 48964-112-24

24

TABLETS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
48964-112-24	2020-07-14	C162847	48780-1	9855d018-d4ed-cd31-e053-dbdaa90ab51a	Nexafed ®
48964-112-24	2019-11-27	C162847	48780-1	9855d018-d4ed-cd31-e053-dbdaa90ab51a	Nexafed ®

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
48964-112-24	EA - Each	48964-112	ec9dc289-b5e7-47fb-9e5e-8a36d9292275	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Nexafed
Pseudoephedrine HCl
SILICON DIOXIDE
CROSPOVIDONE
HYDROXYPROPYL CELLULOSE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48964-112	48964-112-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
CROSPOVIDONE	68401960MK	IACT
HYDROXYPROPYL CELLULOSE	RFW2ET671P	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 143 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	GEL / TOPICAL		222 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	GRANULE, FOR SUSPENSION / ORAL		194 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, DELAYED RELEASE / ORAL		1060 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	POWDER / ORAL		244 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	GEL / TRANSDERMAL		20 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, COATED PELLETS / ORAL		456 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SOLUTION / TOPICAL		200 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, DELAYED RELEASE / ORAL	789.6 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / SUBLINGUAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	INSERT / VAGINAL		8 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION / ORAL		1600 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE / ORAL		1725 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, DELAYED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	SUSPENSION, EXTENDED RELEASE / ORAL		1120 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUPPOSITORY / RECTAL	14 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	39.2 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	PELLET / ORAL		1140 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SUSPENSION / ORAL		4441 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SOLUTION / ORAL	1.8 mg/120ml		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	LOTION, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION, EXTENDED RELEASE / ORAL		70 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		615 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	GRANULE, FOR SUSPENSION / ORAL		278 mg	Exact identifier — unii candidate 28 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ec681764-4711-6bdf-e053-2995a90a8438			0881e041-ef70-4aa6-884d-1044cf86c2a2	2022-11-01	Warnings	Exact identifier spl set id: 0881e041-ef70-4aa6-884d-1044cf86c2a2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.