Topcare Childrens Triacting Nightime Cold and Cough

Topco Associates LLC

Topco Cold & Cough Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL, 1 teaspoon)
• Purpose
• Topcare Childrens Triacting Nightime Cold and Cough Uses
• Warnings
  • Do not use
  • Ask a doctor before use if the child has
  • Ask a doctor or pharmacist before use if the child is
  • When using this product
  • Stop use and ask a doctor if
  • Keep out of reach of children.
• Directions
• Topcare Childrens Triacting Nightime Cold and Cough Other information
• Inactive ingredients
• Questions or comments?
• Principal Display Panel

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

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

Principal Display Panel

See New Warning and Dosing Directions

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