PSEUDOEPHEDRINE NON-DROWSY FORMULA- pseudoephedrine hcl tablet 
Contract Pharmacal Corp

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.

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Pseudoephedrine 60 mg
Non-Drowsy Formula

Drug Facts

Active Ingredient

(in each tablet)
Pseudoephedrine Hydrochloride 60 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 older
  • take 1 tablet every  4  to 6 hours
  • do not take more than 4 tablets in 24 hours
children under 12 years of ageconsult a physician

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

Croscarmellose Sodium, Lactose, Magnesium Stearate,  Microcrystalline Cellulose, Silica and Stearic Acid.

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

R 09/10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4f2e9749-figure-01
PSEUDOEPHEDRINE  NON-DROWSY FORMULA
pseudoephedrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-1215
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code CPC
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10267-1215-330 in 1 BOTTLE
2NDC:10267-1215-62 in 1 CARTON
225 in 1 BLISTER PACK
3NDC:10267-1215-7100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34107/17/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 1/2012
Document Id: 4f2e9749-8fd6-48f6-9708-d54a4480c719
Set id: 4b11aaea-c525-4be9-a2ee-83e1be343990
Version: 2
Effective Time: 20120120
 
Contract Pharmacal Corp