Pseudoephedrine Plus

Dosage form: tablet
Ingredients: PSEUDOEPHEDRINE HYDROCHLORIDE 60mg, CHLORPHENIRAMINE MALEATE 4mg
Labeler: Contract Pharmacal Corp
NDC Code: 10267-1016

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 Plus

Drug Facts

Active Ingredient

(in each tablet)
Pseudoephedrine Hydrochloride 30 mg
Chlorpheniramine Maleate 4 mg

Purposes

Nasal Decongestant
Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever and the common cold
  • itching of the nose and throat,
  • sneezing
  • runny nose
  • itchy, watery eyes
  • nasal congestion

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 are uncertain whether your prescription drug contains an MAOI

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are using sedatives or tranquilizers

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever

When using this product
  • drowsiness may occur
  • avaoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

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.

Directions

adults and children 12 years of age and over
  • take 1 tablet every  4  to 6 hours, not to exceed 4 doses in 24 hours
children 6 to 12 years of age
  • take ½ tablet every  4  to 6 hours, not to exceed 4 doses in 24 hours
children under 6 years of ageconsult a physician

DO NOT EXCEED RECOMMENDED DOSE

Other information

  • store at room temperature (59˚ – 86˚F)

Inactive Ingredients

Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone and Magnesium Silicate.

*This product is not manufactured or distributed by Warner-Lambert Consumer, owner of the registered trademark Sudafed® Cold and Allergy Tablets.

Manufactured by:
CONTRACT PHARMACAL CORP.,
Hauppauge, NY 11788 USA
www.CPCHealth.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PSEUDOEPHEDRINE PLUS 
pseudoephedrine hydrochloride chlorpherniamine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10267-1016
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE60 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE K30 
MAGNESIUM ALUMINUM SILICATE 
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize7mm
FlavorImprint Code1016;1016
Contains    
Packaging
#Item CodePackage Description
1NDC:10267-1016-81 BLISTER PACK (BLISTER PACK) in 1 CARTON
124 TABLET (TABLET) in 1 BLISTER PACK
2NDC:10267-1016-760 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/20/2001
Labeler - Contract Pharmacal Corp (968334974)
Establishment
NameAddressID/FEIOperations
Contract Pharmacal Corp968334974MANUFACTURE

Revised: 01/2012
 
Contract Pharmacal Corp

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.

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