Nasal Decongestant PE description, usages, side effects, indications, overdosage, supplying and lots more!

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Nasal Decongestant PE

FRED'S, INC.

Freds 44-453


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

Nasal decongestant

Nasal Decongestant PE 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 (1-800-222-1222) 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 

Nasal Decongestant PE Other information

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

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

Principal display panel

fred's®

Maximum Strength
Nasal Decongestant PE
Phenylephrine HCl 10 mg | Nasal Decongestant 

Non-Drowsy
Sinus Pressure
Congestion

18 Tablets

Compare to the active ingredient in:
Sudafed PE® Congestion*

DISTRIBUTED BY: fred's Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

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

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE® Congestion.
50844    REV0313E45344

Nasal Decongestant PE
Fred's 44-453

Nasal Decongestant PE

Phenylephrine HCl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-453
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
SILICON DIOXIDE
CARBOXYMETHYLCELLULOSE SODIUM
TRISODIUM CITRATE DIHYDRATE
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:55315-453-44 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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