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nexafed

Acura Pharmaceuticals, Inc.

nexafed


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Pseudoephedrine HCl 30 mg

Nasal decongestant

  • 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

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.

  • 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

  • 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

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

nexafed

nexafed

pseudoephedrine HCL TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48964-112
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 30 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
hydroxypropyl cellulose
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS

Product Characteristics

Color Size Imprint Code Shape
WHITE (mottled) 16 mm X CAPSULE

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-12-10


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Be sure to consult your doctor before taking any medication!
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