RYNEX PE description, usages, side effects, indications, overdosage, supplying and lots more!

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RYNEX PE

EDWARDS PHARMACEUTICALS, INC.

RYNEX PE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active Ingredients
  (in each 5 nil teaspoonful)
Purpose
Brompheniramine Maleate 1 mg Antihistamine
Phenylephrine HCl 2.5 mg Nasal Decongestant

RYNEX PE 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.

RYNEX PE 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

RYNEX PE

BROMPHENIRAMINE MALEATE and PSEUDOEPHEDRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0485-0202
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 1 mg
Pseudoephedrine Hydrochloride Pseudoephedrine 15 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLPARABEN
propylene glycol
water
sorbitol
Sucralose

Product Characteristics

Color
PINK

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0485-0202-16 473 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-03-07


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Be sure to consult your doctor before taking any medication!
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