Skip to Content

← See all Pseudoephedrine Non drowsy formula brands

Pseudoephedrine Non drowsy formula

Medically reviewed on January 22, 2018

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 30mg
Labeler: Contract Pharmacal Corp
NDC Code: 10267-1004

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Pseudoephedrine Non-Drowsy Formula

Drug Facts

Active Ingredient

(in each tablet)
Pseudoephedrine Hydrochloride 30 mg

Purposes

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
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlargement of the prostate gland

Stop use and ask a doctor if
  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a 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 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 agedo 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).

Inactive Ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PSEUDOEPHEDRINE  NON DROWSY FORMULA
pseudoephedrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-1004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorREDScoreno score
ShapeROUNDSize6mm
FlavorImprint Code1004
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-1004-824 TABLET (TABLET) in 1 BOTTLE
2NDC:10267-1004-62 BLISTER PACK (BLISTER PACK) in 1 CARTON
225 TABLET (TABLET) in 1 BLISTER PACK
3NDC:10267-1004-1100 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/21/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp968334974MANUFACTURE

 
Contract Pharmacal Corp

← See all Pseudoephedrine Non drowsy formula brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide