Drug Facts
Composition & Profile
Identifiers & Packaging
PRODUCT PACKAGING The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 00485-0204-16 Rynex DM Liquid ANTIHISTAMINE ∙ ANTITUSSIVE NASAL DECONGESTANT Each 5 mL (one teaspoonful) for oral administration contains: Brompheniramine Maleate, USP..................1 mg Dextromethorphan HBr, USP.......................5 mg Phenylephrine HCl, USP...........................2.5 mg ALCOHOL FREE ∙ DYE FREE GLUTEN FREE ∙ SUGAR FREE ______________________________________________ FOR PROFESSIONAL USE ONLY Tutti-Frutti Flavor Manufactured for: EDWARDS Pharmaceuticals, Inc. Ripley, MS 38663 16 fl oz (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. The labeling for this product includes professional labeling which is not intended for use by the general public. Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663 Iss. 01/12 label back insert
- PRODUCT PACKAGING The packaging below represents the labeling currently used: Principal display panel and side panel for 473 mL label: NDC 00485-0204-16 Rynex DM Liquid ANTIHISTAMINE ∙ ANTITUSSIVE NASAL DECONGESTANT Each 5 mL (one teaspoonful) for oral administration contains: Brompheniramine Maleate, USP..................1 mg Dextromethorphan HBr, USP.......................5 mg Phenylephrine HCl, USP...........................2.5 mg ALCOHOL FREE ∙ DYE FREE GLUTEN FREE ∙ SUGAR FREE ______________________________________________ FOR PROFESSIONAL USE ONLY Tutti-Frutti Flavor Manufactured for: EDWARDS Pharmaceuticals, Inc. Ripley, MS 38663 16 fl oz (473 mL) Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Dispense in a tight, light-resistant container with a child-resistant cap. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. The labeling for this product includes professional labeling which is not intended for use by the general public. Manufactured for: Edwards Pharmaceuticals, Inc., Ripley, MS 38663 Iss. 01/12 label back insert
Overview
Uses temporarily relieves these symptoms due to the common cold, hay fever, (allergic rhinitis) or other upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation 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 upper respiratory allergies: runny nose sneezing itching of nose or throat itchy, watery eyes cough due to minor throat and bronchial irritation nasal congestion reduces swelling of nasal passages
Dosage & Administration
Directions Do not exceed recommended dosage. Adults and children 12 years of age and older: 4 teaspoonfuls (20 mL) every 4 hours, not to exceed 24 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours. Children under 6 years of age: Consult a doctor
Warnings & Precautions
Warnings Do not exceed recommended dosage. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (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 trouble urinating to to an enlarged prostate gland a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema a cough that occurs with too much phlegm (mucus) heart disease high blood pressure thyroid disease diabetes Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose
Purpose Antihistamine Antitussive Nasal Decongestant
Do Not Use
Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (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.
When Using
When using this product excitability may occur, especially in children may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect be careful when driving a motor vehicle or operating machinery
Stop Use & Ask a Doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. new symptoms occur
Keep Out of Reach of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information Store at 59° - 86°F (15° - 30°C)
Questions
Questions? Comments? Call 1-800-543-9560
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