NEXAFED- pseudoephedrine hydrochloride tablet 
Acura Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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nexafed®

Drug Facts

Active ingredients (in each tablet)

Pseudoephedrine HCl 30 mg

Purpose

Nasal decongestant

Uses

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 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

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

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

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

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.

MANUFACTURED FOR:
Acura Pharmaceuticals, Inc.
616 N. North Court, Palatine, IL 60067
Patents Pending

NDC 48964-112-24

24
TABLETS

This is an image of the carton for nexafed®.
NEXAFED 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:48964-112
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
CROSPOVIDONE 
HYDROXYPROPYL CELLULOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorWHITE (mottled) Scoreno score
ShapeCAPSULE (caplet-shaped) Size16mm
FlavorImprint Code X
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48964-112-242 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/10/2012
Labeler - Acura Pharmaceuticals, Inc. (001315530)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Pharmaceuticals, Inc.005286822MANUFACTURE(48964-112)

Revised: 11/2012
Document Id: bb27c349-d154-4974-8dce-4c79ebea9659
Set id: 0881e041-ef70-4aa6-884d-1044cf86c2a2
Version: 1
Effective Time: 20121110
 
Acura Pharmaceuticals, Inc.