Rynex Liquid
FDA Label NDC 0485-0204

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 (NDC 0485-0204). 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 drug facts, purpose, uses, warnings, do not use this product, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients
(in each 5 mL teaspoonful)
Brompheniramine Maleate 1mg
Dextromethorphan Hydrobromide 5 mg
Phenylephrine Hydrochloride 2.5 mg

Purpose

Antihistamine
Antitussive
Nasal Decongestant

Uses

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

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages

Warnings

Do not exceed recommended dosage.

Do Not Use This Product

  • 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 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
  • trouble urinating to to an enlarged prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm (mucus)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

When Using This Product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask A Doctor If

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache.  A persistent cough may be a sign of a serious condition.
  • new symptoms occur

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of The Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not exceed recommended dosage.
Adults and children
12 years of age
and older:



4 teaspoonfuls (20 mL)
every 4 hours, not to
exceed 24 teaspoonfuls
in 24 hours.


Children 6 to under
12 years of age:



2 teaspoonfuls (10 mL)
every 4 hours, not to
exceed 12 teaspoonfuls
in 24 hours.

Children 2 to under
6 years of age:



1 teaspoonful (5 mL)
every 4 hours, not to
exceed 6 teaspoonfuls
in 24 hours.

Children Under 2:
Consult a Physician

Other Information

Store at 59° - 86°F (15° - 30°C)

Inactive Ingredients

Citric Acid, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol, Tutti Frutti Flavor.

Questions? Comments?

Call 1-800-543-9560

Product Packaging

The packaging below represents the labeling currently used:

Principal display panel and side panel for 473 mL label:

NDC 00485-0204-16

Rynex DM Liquid

ANTIHISTAMINE ∙ ANTITUSSIVE
NASAL DECONGESTANT

Each 5 mL (one teaspoonful) for oral administration contains:
Brompheniramine Maleate, USP..................1 mg
Dextromethorphan HBr, USP.......................5 mg
Phenylephrine HCl, USP...........................2.5 mg

ALCOHOL FREE ∙ DYE FREE
GLUTEN FREE ∙ SUGAR FREE

______________________________________________

FOR PROFESSIONAL USE ONLY

Tutti-Frutti Flavor

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

16 fl oz (473 mL)

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

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

THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER.

The labeling for this product includes professional labeling which is not
intended for use by the general public.

Manufactured by:  Great Southern Laboratories, Houston, TX  77099

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

Iss. 01/12






* Please review the disclaimer below.