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Drug Facts
Rynex Pse Liquid
FDA Label NDC 0485-0206
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 Pse (NDC 0485-0206). 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 use this product, do not use this product, unless directed by a doctor, if you have, otc - do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients (in each 5 mL teaspoonful) | Purpose |
|---|---|
| Brompheniramine Maleate 1 mg | Antihistamine |
| Pseudoephedrine HCI 15 mg | 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 passages
Warnings
On not exceed recommended dosage.
Do Not Use 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 MA0I drug. If you do not know if your prescription drug contains an MA0I, ask a doctor or pharmacist before taking this product
Do Not Use This Product, Unless Directed By A Doctor, If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- heart disease
- thyroid disease
- diabetes mellitus
- difficulty in urination due to enlargement of the prostate gland
Otc - Do Not Use
Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When Using This Product
- excitability may occur, especially in children
- may cause drowsiness
- alcohol, sedatives 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 - 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 to 6 hours, not to exceed 16 teaspoonfuls in 24 hours |
| Children 6 to under 12 years of age: | 2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed 8 teaspoonfuls in 24 hours |
| Children 2 to under 6 years of age | 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls in 24 hours |
| 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
Citric Acid, FD&C Red #40, FD&C Yellow #6, Methyl Paraben, Orange flavor, Potassium Citrate, Potassium Sorbate, Propyl Paraben, Propylene Glycol, Purified Water, Sorbitol Solution 70%, Sucralose
Question? Comments?
Call 1-800-543-9560
Principal Display Panel - 473 Ml Bottle Label
NDC 00485-0206-16
Rynex PSE
Antihistamine • Decongestant
Sugar Free • Alcohol Free •
Gluten Free
Each teaspoonful (5 mL)
for oral administration contains:
Brompheniramine Maleate 1 mg
Pseudoephedrine HCI 15 mg
Orange Flavor
FOR PROFESSIONAL USE ONLY
This bottle is not to be
dispensed to consumer.
Tamper evident by foil seal under cap.
Do not used foil seal is broken or missing.
Dispense in a tight container with a child-
resistant cap.
Manufactured for:
EDWARDS
Pharmaceuticals, Inc.
Ripley, MS 38663
16oz. (473 mL)
* Please review the disclaimer below.
