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

Nasal Decongestant PE

H E B

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
HEB 44-453

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Purpose

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

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

Compare to Sudafed PE® Nasal Decongestant active ingredient*

NDC 37808-453-23

H-E-B®
NASAL DECONGESTANT PE
Non-Drowsy / Maximum Strength
Phenylephrine HCl Tablets, 10 mg
Nasal & Sinus Congestion
• Sinus Pressure

Does Not Contain Gluten

72 Tablets, 10 mg Each
1 Pill/Dose

TAMPER EVIDENT: DO NO USE IF CARTON 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®.
50844    ORG111145323

Principal Display Panel
HEB 44-453

Nasal Decongestant PE

Phenylephrine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37808-453
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
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:37808-453-23 4 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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