Topcare Childrens Triacting Nightime Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Topcare Childrens Triacting Nightime Cold and Cough

Topco Associates LLC

Topco Cold & Cough Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Topcare Childrens Triacting Nightime Cold and Cough 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 age 2 teaspoons (tsp)
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use

Topcare Childrens Triacting Nightime Cold and Cough 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?

1-888-423-0139

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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

Topcare Childrens Triacting Nightime Cold and Cough
Cold & Cough Carton

Topcare Childrens Triacting Nightime Cold and Cough

Diphenhydramine HCl, Phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-913
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 6.25 mg

Product Characteristics

Color
PURPLE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:36800-913-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-09-27


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Be sure to consult your doctor before taking any medication!
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