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.

ASSURED®
Children's Cold & Cough

Drug Facts

Active ingredients (in each TSP (5 mL))Purpose
Brompheniramine maleate, USP 1 mgAntihistamine
Dextromethorphan HBr, USP 5 mgCough suppressant
Phenylephrine HCL, USP 2.5 mgNasal decongestant

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

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.

Directions
  • do not take more than 6 doses in any 24-hour
AgeDose
Adults and children 12 year and over4 TSP every 4 hours
Children 6 years to under 12 years2 TSP every 4 hours
Children under 6 yearsDo not use

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

Inactive Ingredients

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

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

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)

ASSURED CHILDRENS COLD AND COUGH 
brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59741-193
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Brompheniramine Maleate (Brompheniramine) Brompheniramine Maleate1 mg  in 5 mL
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide5 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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 
Product Characteristics
ColorPurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59741-193-06118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34111/01/2011
Labeler - Bio-Pharm, Inc. (801652546)

Revised: 11/2011
 
Bio-Pharm, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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