OTC - QUESTIONS SECTION.


Questions Comments. Call 1-423-493-9170.

INDICATIONS & USAGE SECTION.


Uses. temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:cough due to minor throat and bronchial irritationnasal congestionitching of nose or throatrunny noseitchy, watery eyessneezingreduces swelling of nasal passages. cough due to minor throat and bronchial irritation. nasal congestion. itching of nose or throat. runny nose. itchy, watery eyes. sneezing. reduces swelling of nasal passages.

DOSAGE & ADMINISTRATION SECTION.


Directions. Do not exceed recommended dosage.Adults and children12 years of ageand over:3 teaspoonfuls every to hours,not to exceed 18 teaspoonfuls in a24 hour periodChildren to under12 years of age:1 1/2 teaspoonfuls every to hours,not to exceed teaspoonfuls in a24 hour periodChildren under 6years of ageNot recommended for useA special measuring device should be used to give an accurate dose of this product to children under years of age. Giving higher dose than recommended by doctor could result in serious side effects for your child.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. citric acid, cotton candy flavor, FD&C Red 40, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.

OTC - ACTIVE INGREDIENT SECTION.


Drug Facts. Active ingredients (in each mL teaspoonful) Brompheniramine Maleate 1.33 mg Codeine Phosphate 6.33 mg (WARNING: May be habit-forming) Phenylephrine Hydrochloride 3.33 mg Purpose. AntihistamineCough SuppressantNasal Decongestant.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have. heart diseasehigh blood pressurethyroid diseasediabetesglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandchronic pulmonary disease or shortness of breath, or children who are taking other drugsa cough that lasts or is chronic such as occurs with smoking, asthma or emphysemaa cough that occurs with too much phlegm (mucus). heart disease. high blood pressure. thyroid disease. diabetes. glaucoma. breathing problem such as emphysema or chronic bronchitis. trouble urinating due to an enlarged prostate gland. chronic pulmonary disease or shortness of breath, or children who are taking other drugs. cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. cough that occurs with too much phlegm (mucus).

OTC - ASK DOCTOR/PHARMACIST SECTION.


Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - DO NOT USE SECTION.


Do not use this product. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of the reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding, ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. AntihistamineCough SuppressantNasal Decongestant.

OTC - STOP USE SECTION.


Stop use and ask doctor if. nervousness, dizziness, or sleeplessness occurcough or nasal congestion persists for more than week, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.new symptoms occur. nervousness, dizziness, or sleeplessness occur. cough or nasal congestion persists for more than week, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.. new symptoms occur.

OTC - WHEN USING SECTION.


When using this product. excitability may occur, especially in childrenmay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machinerymay cause or aggravate constipation. excitability may occur, especially in children. may cause marked drowsiness. avoid alcoholic drinks. alcohol, sedatives, and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. may cause or aggravate constipation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Product Packaging. The packaging below represents the labeling currently used. Principal display panel and side panel for 354 mL label: NDC 12830-0754-12 M-END PEAntihistamine Antitussive. Nasal DecongestantSugar Free Alcohol FreeCV EACH mL (1 TEASPOONFUL) CONTAINS:Brompheniramine Maleate ..........................1.33 mg Codeine Phosphate.......................................6.33 mg (WARNING: May be habit-forming.) Phenylephrine Hydrochloride.......................3.33 mg Cotton Candy Flavor 12 fl. oz. (354 mL) Mfg. for:R.A. McNeil CompanyChattanooga, TN 37406-3738Rev. 10/14Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.This package not intended for dispensing to the patient.. END PE Labeling. END PE Labeling.

STORAGE AND HANDLING SECTION.


Other information. Store at 59-86F (15-30C).

WARNINGS SECTION.


Warnings. Do not exceed recommended dosage.. Do not use this product. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinsons disease), or for weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask doctor or pharmacist before taking this product. Ask doctor before use if you have. heart diseasehigh blood pressurethyroid diseasediabetesglaucomaa breathing problem such as emphysema or chronic bronchitistrouble urinating due to an enlarged prostate glandchronic pulmonary disease or shortness of breath, or children who are taking other drugsa cough that lasts or is chronic such as occurs with smoking, asthma or emphysemaa cough that occurs with too much phlegm (mucus). heart disease. high blood pressure. thyroid disease. diabetes. glaucoma. breathing problem such as emphysema or chronic bronchitis. trouble urinating due to an enlarged prostate gland. chronic pulmonary disease or shortness of breath, or children who are taking other drugs. cough that lasts or is chronic such as occurs with smoking, asthma or emphysema. cough that occurs with too much phlegm (mucus). Ask doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product. excitability may occur, especially in childrenmay cause marked drowsinessavoid alcoholic drinksalcohol, sedatives, and tranquilizers may increase drowsinessbe careful when driving motor vehicle or operating machinerymay cause or aggravate constipation. excitability may occur, especially in children. may cause marked drowsiness. avoid alcoholic drinks. alcohol, sedatives, and tranquilizers may increase drowsiness. be careful when driving motor vehicle or operating machinery. may cause or aggravate constipation. Stop use and ask doctor if. nervousness, dizziness, or sleeplessness occurcough or nasal congestion persists for more than week, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.new symptoms occur. nervousness, dizziness, or sleeplessness occur. cough or nasal congestion persists for more than week, tends to recur, or is accompanied by fever, rash or persistent headache. These could be signs of serious condition.. new symptoms occur. If pregnant or breast-feeding, ask health professional before use.. Keep out of the reach of children.. In case of overdose, get medical help or contact Poison Control Center right away.