Drug Facts
Composition & Profile
Identifiers & Packaging
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) Rynex0206
- 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) Rynex0206
Overview
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
Indications & Usage
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
Dosage & Administration
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 under 6 years of age Consult a doctor
Warnings & Precautions
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 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 Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Purpose
Active Ingredients (in each 5 mL teaspoonful) Purpose Brompheniramine Maleate 1 mg Antihistamine Pseudoephedrine HCI 15 mg Decongestant
Do Not Use
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 Do not lake this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
When Using
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 & Ask a Doctor
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
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.
Storage & Handling
Other information Store at 59° - 86° F (15° - 30 C) [see USP for Controlled Room Temperature]
Questions
Question? Comments? Call 1-800-543-9560
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