Pseudoephedrine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Pseudoephedrine Hydrochloride

Physicians Total Care, Inc.

SudoGestNasal Decongestant


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Pseudoephedrine HCl 60 mg

Purpose

Nasal decongestant

Pseudoephedrine Hydrochloride 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
  • thyroid disease
  • heart disease
  • high blood pressure
  • trouble urinating due to enlargement of the 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 pregrant 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 older: take 1 tablet every 4 to 6 hours. Do not take more than 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Pseudoephedrine Hydrochloride Other information

  • store at controlled room temperature 15˚-30˚C (59˚-86˚F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, stearic acid

Principal display panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available


FOR PHARMACY USE ONLY.

NOT FOR RETAIL SALE.

NDC 54868-1973-1

Pseudoephedrine Hydrochloride

NASAL DECONGESTANT  60 mg

Relieves Nasal and Sinus Congestion due to Colds or Hay Fever

Without Drowsiness

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


50844  Rev. 0807L11302

Distributed by Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA   M-17

Rev. 10/10      Re-order No. 700324






Pseudoephedrine Hydrochloride

Pseudoephedrine Hydrochloride TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54868-1973(NDC:0904-5125)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Pseudoephedrine Hydrochloride Pseudoephedrine 60 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
LACTOSE
MAGNESIUM STEARATE
polyethylene glycol
SILICON DIOXIDE
STEARIC ACID
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
WHITE 8 mm 44;113 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54868-1973-1 20 in 1 BOTTLE
2 NDC:54868-1973-3 100 in 1 BOTTLE
3 NDC:54868-1973-4 30 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-11-25


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Be sure to consult your doctor before taking any medication!
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