Medication Guide App

Topcare Childrens Cold and Allergy Elixer

Dosage form: liquid
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL, BROMPHENIRAMINE MALEATE 1mg in 5mL
Labeler: Topco Associates LLC
NDC Code: 36800-906

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.

Topco Cold and Allergy Elixir Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Nasal decongestant

Uses
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis):
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy, watery eyes
  • temporarily restores freer breathing through the nose

Warnings

Do not use
  • 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.
  • to make a child sleepy

Ask a doctor before use if you have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product
  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic beverages
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • 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

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 right away.

Directions
  • do not take more than 6 doses in any 24-hour period
agedose
adults and children 12 years and over4 tsp every 4-6 hours
children 6 to under 12 years2 tsp every 4-6 hours
children 4 to under 6 yearsdo not use unless directed by a doctor
children under 4 yearsdo not use

Other information
  • each teaspoon contains: sodium 2 mg
  • store at 20°-25°C (68°-77°F)
  • not a USP elixir

Inactive ingredients

citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warning and Dosing Directions

Alcohol Free

Children’s

Cold & Allergy

Elixir

Antihistamine (Brompheniramine Maleate)

Nasal Decongestant (Phenylephrine HCl)

Relieves:

Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Sneezing

Grape Flavor

Compare to Children's Dimetapp® Elixir Cold & Allergy active ingredients

Cold and Allergy Elixir Carton

TOPCARE CHILDRENS COLD AND ALLERGY ELIXER 
phenylephrine hcl, brompheniramine maleate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-906
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
Product Characteristics
ColorPURPLE (clear bluish-red) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-906-261 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:36800-906-341 BOTTLE (BOTTLE) in 1 CARTON
2236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/21/2006
Labeler - Topco Associates LLC (006935977)

Revised: 07/2009
 
Topco Associates LLC

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.

Hide
(web4)