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RYNEX PE

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 1mg in 5mL, PSEUDOEPHEDRINE HYDROCHLORIDE 15mg in 5mL
Labeler: EDWARDS PHARMACEUTICALS, INC.
NDC Code: 0485-0202

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 PE

Drug Facts

Active Ingredients
  (in each 5 nil teaspoonful)
Purpose
Brompheniramine Maleate 1 mgAntihistamine
Phenylephrine HCl 2.5 mgNasal Decongestant

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 passage

Warnings

Do not exceed recommended dosage.

Do not take 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 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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes mellitus
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor before use if you are taking sedatives or tranquilizers.

When using this product
  • excitability may occur, especially in children
  • may cause drowsiness
  • sedalives 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

If pregnant or breast feeding, ask a health professional before use.

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 hours, not to exceed 24 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:2 teaspoonfuls(10 mL) every 4 hours, not to exceed 1 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 6 teaspoonfuls in 24 hours, or as directed by a doctor.
Children under 2 years of age:Consult a doctor.

Other information

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

Inactive ingredients

Bubblegum Flavor, Citric Acid, FD&C Red #40, Methyl Paraben, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose.

Questions Comments?

Call 1-800-543-9560

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Rynex PE

E

NDC 0485-0202-16

Rynex PE
Antihistamine • Nasal Decongestant

Sugar Free • Alcohol Free
• Gluten Free

Each teaspoonful (5 mL)
for oral administration contains:

Brompheniramine Maleate 1 mg
Phenylephrine HCl 2.5 mg

Bubblegum Flavor
FOR PROFESSIONAL USE ONLY

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

Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663

16oz. (473 mL)

RYNEX PE 
brompheniramine maleate and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0202
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 
METHYLPARABEN 
POTASSIUM CITRATE 
POTASSIUM SORBATE 
PROPYLPARABEN 
PROPYLENE GLYCOL 
WATER 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorPINKScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0485-0202-16473 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.

Medically reviewed on Apr 2, 2018

Further information

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

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