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

Childrens Cold and Cough

Kroger Company

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Kroger Co. Children’s Cold & Cough 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

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. (1-800-222-1222)

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 #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredients of CHILDREN’S DIMETAPP® DM ELIXIR COLD & COUGH

See side panel

Children’s

Cold & Cough

Elixir

Brompheniramine Maleate

Antihistamine

Dextromethorphan HBr, Cough Suppressant

Phenylephrine HCl, Nasal Decongestant

Multi-Symptom Relief:

Nasal Congestion

Runny Nose

Itchy, Watery Eyes

Coughing, Sneezing

Alcohol Free

Grape Flavor

4 FL OZ (118 mL)

Childrens Cold and Cough

Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:30142-987
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

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
propylene glycol
water
saccharin sodium
SODIUM BENZOATE
sorbitol

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:30142-987-26 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2007-08-21


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Be sure to consult your doctor before taking any medication!
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