Leader Childrens Cold and Allergy

Manufacturer: Cardinal Health
Effective date: 2019-07-24
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:17:33

Label at a glance#

ProductLeader Childrens Cold and Allergy

Active ingredientPHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE

Label structure9 sections

Indications and 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

Dosage and administration

• 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

Storage and handling

• each teaspoon contains: sodium 2 mg • store at 20°-25°C (68°-77°F) • not a USP elixir

Contacts and useful links#

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

you get nervous, dizzy or sleepless
symptoms do not get better within 7 days or are accompanied by fever

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

each teaspoon contains: sodium 2 mg
store at 20°-25°C (68°-77°F)
not a USP elixir

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1053258	Brompheniramine/Phenylephrine (Oral Liquid)	brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD Active

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
37205-931-26	ML - Milliliter	37205-931	942228e7-4f25-45c7-b880-edca68e280b6	1	2012-07-24
37205-931-34	ML - Milliliter	37205-931	a958098c-b38b-4160-89c5-36e8307713d8	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BROMPHENIRAMINE MALEATE	ACTIVE INGREDIENT	IXA7C9ZN03	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	1
BROMPHENIRAMINE	ACTIVE MOIETY	H57G17P2FN	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

Leader Childrens Cold and Allergy
phenylephrine hcl, brompheniramine maleate
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
BROMPHENIRAMINE MALEATE
BROMPHENIRAMINE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
GLYCERIN
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SORBITOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
37205-931	37205-931-26, 37205-931-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
BROMPHENIRAMINE MALEATE	IXA7C9ZN03	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
GLYCERIN	PDC6A3C0OX	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SORBITOL	506T60A25R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fae11dd2-aecc-4b33-8281-233f632c9235			bcc8a46c-ba10-4e08-a7ed-d06b4f016847	2020-12-03	Warnings	Exact identifier spl set id: bcc8a46c-ba10-4e08-a7ed-d06b4f016847

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.