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

Nasal Decongestant

Rugby Laboratories, Inc
Time Cap Labs, Inc

  • 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
DRUG FACTS



FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient (in each tablet)

Purpose

Purpose

Uses

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies
  • temporarily restores freer breathing through the nose
Warnings
Do not use
Ask a doctor before use if you have
  • high blood pressure
  • heart disease
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
When using this product
  • do not use more than directed
Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • symptoms do not improve within 7 days or accompanied by fever
If pregnant or breast-feeding,
Keep out of reach of children.
Directions
  • take every 4-6 hours
  • do not take more than 4 doses in 24 hours


do not use
Other information
  • store at 25°C (77°F), excursions permitted between 15°-30°C (59°-86°F)
  • protect from light
Inactive ingredients
Questions or comments? 1-800-645-2158


Nasal Decongestant

Pseudoephedrine HCl TABLET, SUGAR COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-4391
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
ACACIA
CALCIUM SULFATE ANHYDROUS
carnauba wax
SILICON DIOXIDE
STARCH, CORN
D&C RED NO. 27
D&C YELLOW NO. 10
FD&C RED NO. 40
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
KAOLIN
cellulose, microcrystalline
polyethylene glycol 400
STARCH, CORN
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCROSE
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
red 7 mm TCL;016 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-4391-35 24 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-09-22


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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