NEXAFED- pseudoephedrine hcl 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 ®

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

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

NEXAFED 
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48964-112
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (UNII: 68401960MK)  
HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
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 CARTON07/10/202012/11/2021
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/10/202012/11/2021
Labeler - Acura Pharmaceuticals, Inc. (001315530)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Pharmaceuticals, Inc.005286822api manufacture(48964-112)

Revised: 11/2022
 
Acura Pharmaceuticals, Inc.