LEADER CHILDRENS COLD AND ALLERGY- phenylephrine hcl, brompheniramine maleate liquid

Leader Childrens Cold and Allergy by

Drug Labeling and Warnings

Leader Childrens Cold and Allergy by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each 5 mL teaspoonful)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

Antihistamine

Nasal decongestant

Uses

• temporarily relieves 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

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• do not use more than directed
• drowsiness may occur
• 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

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 & Allergy active ingredients

For Ages 6 yrs. & Over

Children’s

Cold & Allergy

Elixir

Antihistamine (Brompheniramine Maleate)

Nasal Decongestant (Phenylephrine HCl)

Relieves:

Nasal Congestion

Sneezing

Runny Nose

Itchy, Watery Eyes

Grape Flavor

Alcohol-Free

Children's Cold and Allergy Elixir Carton

Children's Cold and Allergy Elixir Carton

INGREDIENTS AND APPEARANCE

LEADER CHILDRENS COLD AND ALLERGY 
phenylephrine hcl, brompheniramine maleate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-931
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	PURPLE (clear bluish-red)	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-931-26	1 in 1 CARTON	10/30/2006
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 37205-931-34	1 in 1 CARTON	10/30/2006	02/12/2012
2		237 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/30/2006

Labeler - Cardinal Health (097537435)