DOSAGE & ADMINISTRATION SECTION.
Directions. Do not exceed recommended dosageAdults and children 12 years of age and over:4 teaspoonfuls (20 mL) every to hours, not to exceed 16 teaspoonfuls in 24 hours Children to under 12 years of age:2 teaspoonfuls (10 mL) every to hours, not to exceed teaspoonfuls in 24 hoursChildren under years of ageConsult doctor.
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INACTIVE INGREDIENT SECTION.
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.
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INDICATIONS & USAGE SECTION.
Uses. temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other respiratory allergies:runny nosesneezingitching of the nose or throatitchy, watery eyesnasal congestion reduces swelling of nasal passages. runny nose. sneezing. itching of the nose or throat. itchy, watery eyes. nasal congestion reduces swelling of nasal passages.
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OTC - ACTIVE INGREDIENT SECTION.
Active Ingredients (in each mL teaspoonful)PurposeBrompheniramine Maleate mgAntihistaminePseudoephedrine HCI 15 mgDecongestant.
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OTC - DO NOT USE SECTION.
Do not use this product. if you are now taking prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask doctor or pharmacist before taking this product. if you are now taking prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask doctor or pharmacist before taking this product.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION.
Keep out of reach of children. In case of accidental overdose, seek professional help or contact Poison Control Center immediately.
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OTC - PURPOSE SECTION.
Active Ingredients (in each mL teaspoonful)PurposeBrompheniramine Maleate mgAntihistaminePseudoephedrine HCI 15 mgDecongestant.
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OTC - QUESTIONS SECTION.
Question Comments. Call 1-800-543-9560.
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OTC - STOP USE SECTION.
Stop use and ask doctor If. nervousness, dizziness, or sleeplessness occurIf symptoms do not improve within days or are accompanied by fever, consult doctornew symptoms occur. nervousness, dizziness, or sleeplessness occur. If symptoms do not improve within days or are accompanied by fever, consult doctor. new symptoms occur.
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OTC - WHEN USING SECTION.
When using this product. excitability may occur, especially in childrenmay cause drowsinessalcohol, sedatives and tranquilizers may increase drowsiness effectavoid alcoholic beveragesuse caution when driving motor vehicle or operating machinery. excitability may occur, especially in children. may cause drowsiness. alcohol, sedatives and tranquilizers may increase drowsiness effect. avoid alcoholic beverages. use caution when driving motor vehicle or operating machinery.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL 473 mL Bottle Label. NDC 00485-0206-16Rynex PSEAntihistamine DecongestantSugar Free Alcohol Free Gluten Free Each teaspoonful (5 mL) for oral administration contains: Brompheniramine Maleate 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 tight container with child- resistant cap. Manufactured for: EDWARDS Pharmaceuticals, Inc. Ripley, MS 38663 16oz. (473 mL) label.
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SPL UNCLASSIFIED SECTION.
Drug Facts.
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STORAGE AND HANDLING SECTION.
Other information. Store at 59 86 (15 30 C) [see USP for Controlled Room Temperature].
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WARNINGS SECTION.
Warnings. On not exceed recommended dosage.. Do not use this product. if you are now taking prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask doctor or pharmacist before taking this product. if you are now taking prescription monoamine oxidase inhibitor (MA0I) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MA0I drug. If you do not know if your prescription drug contains an MA0I, ask doctor or pharmacist before taking this product. Do not use this product, unless directed by doctor, if you have. breathing problem such as emphysema or chronic bronchitisglaucomaheart diseasethyroid diseasediabetes mellitusdifficulty in urination due to enlargement of the prostate gland. 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 childrenmay cause drowsinessalcohol, sedatives and tranquilizers may increase drowsiness effectavoid alcoholic beveragesuse caution when driving motor vehicle or operating machinery. excitability may occur, especially in children. may cause drowsiness. alcohol, sedatives and tranquilizers may increase drowsiness effect. avoid alcoholic beverages. use caution when driving motor vehicle or operating machinery. Stop use and ask doctor If. nervousness, dizziness, or sleeplessness occurIf symptoms do not improve within days or are accompanied by fever, consult doctornew symptoms occur. nervousness, dizziness, or sleeplessness occur. If symptoms do not improve within days or are accompanied by fever, consult doctor. new symptoms occur. Keep out of reach of children. In case of accidental overdose, seek professional help or contact Poison Control Center immediately.
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