Assured Childrens Cold and Cough Brompheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride Brompheniramine Maleate Brompheniramine Dextromethorphan Hydrobromide Dextromethorphan Phenylephrine Hydrochloride Phenylephrine saccharin sodium Citric Acid Monohydrate FD&C Red No. 40 Glycerin Water Sodium Benzoate Sodium Citrate Sorbitol Propylene Glycol Vitis Vinifera Fruit Oil FD&C Blue NO. 1
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 59741-193-06 ASSURED® See New Warning & Dosing Directions Children's Cold & Cough Antihistamine: Brompheniramine Maleate Cough Suppressant: Dextromethorphan HBr Nasal Decongestant: Phenylephrine HCl Relieves: • Stuffy Nose • Runny Nose • Sneezing • Coughing • Itchy, Watery Eyes Alcohol-Free Grape Flavor 4 FL OZ (118 mL) Principal Display Panel - 118 mL Bottle Label
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label NDC 59741-193-06 ASSURED® See New Warning & Dosing Directions Children's Cold & Cough Antihistamine: Brompheniramine Maleate Cough Suppressant: Dextromethorphan HBr Nasal Decongestant: Phenylephrine HCl Relieves: • Stuffy Nose • Runny Nose • Sneezing • Coughing • Itchy, Watery Eyes Alcohol-Free Grape Flavor 4 FL OZ (118 mL) Principal Display Panel - 118 mL Bottle Label
Overview
Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of nose or throat temporarily restores freer breathing through the nose
Indications & Usage
Uses temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves these symptoms due to hay fever (allergic rhinitis): runny nose sneezing itchy, watery eyes itching of nose or throat temporarily restores freer breathing through the nose
Dosage & Administration
Directions do not take more than 6 doses in any 24-hour Age Dose Adults and children 12 year and over 4 TSP every 4 hours Children 6 years to under 12 years 2 TSP every 4 hours Children under 6 years Do not use
Warnings & Precautions
Warnings Do not use to sedate a child or make a child sleepy 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 MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant taking sedatives or tranquilizers When using this product do not use more than directed may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness do not use more than directed be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache These could be signs of a serious condition. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Purpose
Active ingredients (in each TSP (5 mL)) Purpose Brompheniramine maleate, USP 1 mg Antihistamine Dextromethorphan HBr, USP 5 mg Cough suppressant Phenylephrine HCL, USP 2.5 mg Nasal decongestant
Do Not Use
Do not use to sedate a child or make a child sleepy 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 MAOI, ask a doctor or pharmacist before taking this product.
When Using
When using this product do not use more than directed may cause marked drowsiness avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness do not use more than directed be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Stop Use & Ask a Doctor
Stop use and ask a doctor if you get nervous, dizzy or sleepless symptoms do not get better within 7 days or are accompanied by fever cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache These could be signs of a serious condition.
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Storage & Handling
Other information each TSP (5mL) contains: sodium 3 mg TAMPER-EVIDENT: Do not use if foil seal over the mouth of the bottle is torn, broken or missing Store at 20°-25°C (68°-77°F) dosage cup provided
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