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Assured Childrens Cold and Cough
Dosage form: liquid
Ingredients: Brompheniramine Maleate 1mg in 5mL, Dextromethorphan Hydrobromide 5mg in 5mL, Phenylephrine Hydrochloride 2.5mg in 5mL
Labeler: Bio-Pharm, Inc.
NDC Code: 59741-193
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Children's Cold & Cough
|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|
- 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
- itchy, watery eyes
- itching of nose or throat
- temporarily restores freer breathing through the nose
- 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.
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate
- 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
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
- 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
- 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.
- do not take more than 6 doses in any 24-hour
|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|
- 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
citric acid anhydrous, FD&C blue#1, FD&C red #40, glycerin, flavor, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium saccharin, sorbitol
Levittown, PA 19057
See New Warning & Dosing Directions
Cold & Cough
Antihistamine: Brompheniramine Maleate
Cough Suppressant: Dextromethorphan HBr
Nasal Decongestant: Phenylephrine HCl
• Stuffy Nose • Runny Nose • Sneezing
• Coughing • Itchy, Watery Eyes
4 FL OZ (118 mL)
|ASSURED CHILDRENS COLD AND COUGH
brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
|Labeler - Bio-Pharm, Inc. (801652546)|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.