Topcare Childrens Triacting Nightime Cold and Cough

Dosage form: liquid
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL, DIPHENHYDRAMINE HYDROCHLORIDE 6.25mg in 5mL
Labeler: Topco Associates LLC
NDC Code: 36800-913

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 & Cough Drug Facts

Active ingredient (in each 5 mL, 1 teaspoon)

Diphenhydramine HCl, USP 6.25 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine/cough suppressant

Nasal decongestant

Uses
  • temporarily relieves
  • itchy, watery eyes due to hay fever
  • sneezing
  • nasal and sinus congestion
  • runny nose
  • itchy nose or throat
  • cough due to minor throat and bronchial irritation

Warnings

Do not use
  • in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if the child has
  • high blood pressure
  • thyroid disease
  • glaucoma
  • diabetes
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as chronic bronchitis
  • cough that lasts or is chronic such as occurs with asthma
  • heart disease

Ask a doctor or pharmacist before use if the child is

taking sedatives or tranquilizers

When using this product
  • do not exceed recommended dosage
  • may cause marked drowsiness
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop use and ask a doctor if
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not get better within 7 days or occur with fever
  • cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. A persistent cough may be a sign of a serious condition.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • take every 4 hours; not to exceed 6 doses in 24 hours or as directed by a doctor
children 6 to under 12 years of age2 teaspoons (tsp)
children 4 to under 6 years of agedo not use unless directed by a doctor
children under 4 years of agedo not use

Other information
  • each teaspoon contains: sodium 3 mg
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions or comments?

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Alcohol Free

Children’s

Triacting

Nighttime

Cold & Cough

Antihistamine/Cough Suppressant (Diphenhydramine HCl)

Nasal Decongestant (Phenylephrine HCl)

Cough Relief

Runny, Stuffy Nose

Itchy Throat

Grape Flavor

Compare to Triaminic® Night Time Cold & Cough active ingredients

Cold & Cough Carton

TOPCARE CHILDRENS TRIACTING NIGHTIME COLD AND COUGH 
diphenhydramine hcl, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-913
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg  in 5 mL
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-913-261 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/27/2007
Labeler - Topco Associates LLC (006935977)

Revised: 09/2009
 
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.

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