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

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Pseudoephedrine

Contract Pharmacal Corp




FULL PRESCRIBING INFORMATION

Drug Facts

(in each tablet)
Pseudoephedrine Hydrochloride 30 mg

Nasal Decongestant

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

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.

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlargement of the prostate gland
  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever

ask a health professional before use.

In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years of age and over
  • take 2 tablets every  4  to 6 hours
  • do not take more than 8 tablets in 24 hours
children 6 to 12 years of age
  • take 1 tablet every  4  to 6 hours
  • do not take more than 4 tablets in 24 hours
children under 6 years of age do not use this product in children under 6 years of age

DO NOT EXCEED RECOMMENDED DOSE

Other information

  • store at room temperature, USP
  • side effects occur. You may report side effects to the FDA at 1-800-FDA-1088 (Toll Free).

Calcium Sulfate, Carnauba Wax, Croscarmellose Sodium, D&C Red #40 Lake, FD&C Yellow #6 Lake, Gelatin, Kaolin, Lactose, Magnesium Silicate, Microcrystalline Cellulose, Pharmaceutical Glaze, Silica, Stearic Acid, Sugar and Titanium Dioxide

*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Sudafed® Congestion.

Manufactured by:
Contract Pharmacal Corp.,
135 Adams Ave
Hauppauge, NY 11788 USA
www.CPCHealth.com

R 09/10

Pseudoephedrine

Pseudoephedrine

Pseudoephedrine Hydrochloride TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10267-1004
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
CALCIUM SULFATE
carnauba wax
CROSCARMELLOSE SODIUM
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
KAOLIN
lactose monohydrate
magnesium aluminum silicate
MAGNESIUM STEARATE
cellulose, microcrystalline
SHELLAC
SILICON DIOXIDE
STEARIC ACID
raw sugar
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
RED 6 mm 1004 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10267-1004-8 24 in 1 BOTTLE
2 25 in 1 BLISTER PACK
3 NDC:10267-1004-1 100 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2001-06-21


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