Leader Childrens Cold and Cough description, usages, side effects, indications, overdosage, supplying and lots more!

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Leader Childrens Cold and Cough

Cardinal Health

Cardinal Health Children's Cold and Cough Elixir Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each 5 mL teaspoonful)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Cough suppressant

Nasal decongestant

Leader Childrens Cold and Cough 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):
  • 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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • thyroid disease
  • high blood pressure
  • heart disease
  • diabetes
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

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
  • 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 for more than 7 days, comes back, or occurs with fever, rash or persistent headache. A persistent cough may be a sign 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 right away.

Directions

  • do not take more than 6 doses in any 24-hour period
age dose
adults and children 12 years and over 4 tsp every 4-6 hours
children 6 to under 12 years 2 tsp every 4-6 hours
children 4 to under 6 years do not use unless directed by a doctor
children under 4 years do 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? 

1-800-719-9260

Principal Display Panel

Compare to Dimetapp® Cold & Cough active ingredients

For Ages 6 yrs. & Over

Children’s

Cold & Cough

Elixir

Antihistamine (Brompheniramine Maleate)

Cough Suppressant (Dextromethorphan HBr)

Nasal Decongestant (Phenylephrine HCl)

Relieves:
Nasal Congestion, Runny Nose,

Itchy, Watery Eyes

Coughing, Sneezing

Red Grape Flavor

Alcohol-Free

Leader Childrens Cold and Cough
Children's Cold and Cough Elixir Carton

Leader Childrens Cold and Cough

Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-969
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Brompheniramine Maleate BROMPHENIRAMINE 1 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Product Characteristics

Color
PURPLE (Clear bluish-red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE
2 NDC:37205-969-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2007-04-26


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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