nexafed

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Acura Pharmaceuticals, Inc.
NDC Code: 48964-112

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.

nexafed®

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 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

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 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

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  • 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

NEXAFED 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem 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 CodeX
Contains    
Packaging
#Item CodePackage Description
1NDC:48964-112-242 BLISTER PACK (BLISTER PACK) in 1 CARTON
112 TABLET (TABLET) 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/FEIOperations
Patheon Pharmaceuticals, Inc.005286822MANUFACTURE(48964-112)

Revised: 11/2012
 
Acura Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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