Non-Drowsy Nasal Decongestant description, usages, side effects, indications, overdosage, supplying and lots more!

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Non-Drowsy Nasal Decongestant

Greenbrier International, Inc.

Assured 44-453


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Non-Drowsy Nasal Decongestant Uses

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

  • temporarily relieves sinus congestion and pressure

Warnings

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 drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

  • diabetes

  • heart disease

  • high blood pressure

  • thyroid disease

  • trouble urinating due to an enlarged prostate gland

When using this product

do not exceed recommended dose.

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur

  • symptoms do not improve within 7 days or occur with fever

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: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.

  • children under 12 years: do not use this product in children under 12 years of age

Non-Drowsy Nasal Decongestant Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dextrose monohydrate, dicalcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silica gel, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Item Number 932206
NDC 33992-453-08
*Compare to The Active Ingredient of Sudafed PE®

ASSURED™

Non-Drowsy
NASAL
DECONGESTANT

Phenylephrine HCl 10 mg • Nasal decongestant
DOES NOT CONTAIN PSEUDOEPHEDRIN

  • Congestion
  • Sinus Pressure

24 TABLETS

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®.
50844        REV1111A45308

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS BROKEN, TORN OR SHOWS ANY SIGNS OF TAMPERING

Non-Drowsy Nasal Decongestant
Assured 44-453

Non-Drowsy Nasal Decongestant

Phenylephrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0453
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
Dextrose monohydrate
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C RED NO. 40
MAGNESIUM STEARATE
maltodextrin
cellulose, microcrystalline
CARBOXYMETHYLCELLULOSE SODIUM
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 6 mm 44;453 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 18 in 1 BLISTER PACK
2 NDC:33992-0453-8 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2004-12-06


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Be sure to consult your doctor before taking any medication!
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