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RYNEX PSE

Medically reviewed on April 5, 2018

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 1mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 15mg in 5mL
Labeler: EDWARDS PHARMACEUTICALS, INC.
NDC Code: 0485-0206

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.

RYNEX PSE

Drug Facts

Active Ingredients (in each 5 mL teaspoonful)Purpose
Brompheniramine Maleate 1 mgAntihistamine
Pseudoephedrine HCI 15 mgDecongestant

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes
  • nasal congestion 'reduces swelling of nasal passages

Warnings

On not exceed recommended dosage.

Do not use this product
  • if you are now taking a prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product

Do not use this product, unless directed by a doctor, if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.

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

Stop use and ask doctor If
  • nervousness, dizziness, or sleeplessness occur
  • If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor
  • new symptoms occur

Keep out of reach of children.

In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.

Directions

Do not exceed recommended dosage

Adults and children 12 years of age and over:4 teaspoonfuls (20 mL) every 4 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours
Children 6 to under 12 years of age:2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours
Children 2 to under 6 years of age1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours
Children under 2 years of ageConsult a doctor

Other information

Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]

Inactive ingredients

Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose

Question? Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC 00485-0206-16

Rynex PSE

Antihistamine • Decongestant

Sugar Free • Alcohol Free •
Gluten Free

Each teaspoonful (5 mL)
for oral administration contains:

Brompheniramine Maleate     1 mg
Pseudoephedrine HCI           15 mg

Orange Flavor
FOR PROFESSIONAL USE ONLY

This bottle is not to be
dispensed to consumer.

Tamper evident by foil seal under cap.
Do not used foil seal is broken or missing.

Dispense in a tight container with a child-
resistant cap.

Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663
16oz. (473 mL)

RYNEX PSE 
brompheniramine maleate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0206
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (PSEUDOEPHEDRINE) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorORANGEScore    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0485-0206-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/07/2011
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)

 
EDWARDS PHARMACEUTICALS, INC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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