Rynex Pe Liquid
FDA Label NDC 0485-0202

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Edwards Pharmaceuticals, Inc. for the product Rynex Pe (NDC 0485-0202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not take this product, ask a doctor before use if you have, otc - ask doctor, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

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

Otc - Ask Doctor

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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)

* Please review the disclaimer below.