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  5. Label Information: Rynex Pe

FDA Label for Rynex Pe

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT TAKE THIS PRODUCT
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS COMMENTS?
    16. PRINCIPAL DISPLAY PANEL - 473 ML BOTTLE LABEL

Rynex Pe Product Label

The following document was submitted to the FDA by the labeler of this product Edwards Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.