RYNEX PE- brompheniramine maleate and phenylephrine hcl liquid 
EDWARDS PHARMACEUTICALS, INC.

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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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:

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 under 6 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)

label

RYNEX PE 
brompheniramine maleate and phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0485-0202
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0485-0202-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/07/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/07/2011
Labeler - EDWARDS PHARMACEUTICALS, INC. (195118880)
Establishment
NameAddressID/FEIBusiness Operations
Llorens Pharmaceutical037342305manufacture(0485-0202)

Revised: 1/2023
Document Id: efbada87-3472-ed2a-e053-2a95a90a08eb
Set id: 77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef
Version: 6
Effective Time: 20230101
 
EDWARDS PHARMACEUTICALS, INC.