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

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.