NEXAFED- pseudoephedrine hcl tablet

nexafed by

Drug Labeling and Warnings

nexafed by is a Otc medication manufactured, distributed, or labeled by Acura Pharmaceuticals, Inc., Patheon Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

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

Warnings

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.

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 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

PREGNANCY OR BREAST FEEDING

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.

Directions

• 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

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

INACTIVE INGREDIENT

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

nexafed®
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:
Acura Pharmaceuticals, Inc.
616 N. North Court, Palatine, IL 60067
Patents Pending

NDC: 48964-112-24

24
TABLETS

INGREDIENTS AND APPEARANCE

NEXAFED 
pseudoephedrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48964-112
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	WHITE (mottled)	Score	no score
Shape	CAPSULE (caplet-shaped)	Size	16mm
Flavor		Imprint Code	X
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48964-112-24	2 in 1 CARTON
1		12 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	12/10/2012

Labeler - Acura Pharmaceuticals, Inc. (001315530)

Establishment
Name	Address	ID/FEI	Business Operations
Patheon Pharmaceuticals, Inc.		005286822	MANUFACTURE(48964-112)