Drug Facts

Drug Facts

SPL v5

SPL

SPL Set ID 10cc7d67-30c4-4451-bf74-78abae3c8e25

Route

ORAL

Published

Effective Date 2024-02-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Brompheniramine (2 mg) Phenylephrine (5 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Sodium Benzoate Trisodium Citrate Dihydrate Sorbitol Sucralose Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-04-30

Description

Brompheniramine maleate 2 mg Phenylephrine HCI 5 mg

Purpose

Antihistamine Nasal decongestant

Medication Information

Purpose

Antihistamine Nasal decongestant

Description

Brompheniramine maleate 2 mg Phenylephrine HCI 5 mg

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)
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
temporarily restores freer breathing through the nose

Purposes

Antihistamine

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 years	10 mL every 4 hours
children under 6 years	do not use

Do Not Use

to sedate a child or to make a child sleepy
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.

Package Label

LEADER Children's Cold & Allergy Grape Flavor

Other Information

each 10 mL contains: sodium 6 mg
store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO CHILDREN'S DIMETAPP® COLD & ALLERGY active ingredients*

Children Cold & Allergy

Brompheniramine Maleate,2 mg

Phenylephrine HCl, 5 mg

Antihistamine

Nasal Decongestant

Grape Flavor

Alcohol-Free

For Ages 6 Years & Over

Relieves

Itchy, Watery Eyes

Runny Nose

Sneezing

Stuffy Nose

Itching of the Nose or Throat

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

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

nervousness, dizziness or sleeplessness occur
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 (1-800-222-1222) right away.

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate 2 mg

Phenylephrine HCI 5 mg

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 any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

Structured Label Content

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)
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
temporarily restores freer breathing through the nose

Purposes

Antihistamine

Nasal decongestant

Directions

do not take more than 6 doses in any 24-hour period
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
mL = milliliter

age	dose
adults and children 12 years and over	20 mL every 4 hours
children 6 to 11 years	10 mL every 4 hours
children under 6 years	do not use

Do Not Use (Do not use)

to sedate a child or to make a child sleepy
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.

Package Label

LEADER Children's Cold & Allergy Grape Flavor

Other Information (Other information)

each 10 mL contains: sodium 6 mg
store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO CHILDREN'S DIMETAPP® COLD & ALLERGY active ingredients*

Children Cold & Allergy

Brompheniramine Maleate,2 mg

Phenylephrine HCl, 5 mg

Antihistamine

Nasal Decongestant

Grape Flavor

Alcohol-Free

For Ages 6 Years & Over

Relieves

Itchy, Watery Eyes

Runny Nose

Sneezing

Stuffy Nose

Itching of the Nose or Throat

FL OZ (mL)

Dosing Cup Included

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

When Using This Product (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 (Stop use and ask a doctor if)

nervousness, dizziness or sleeplessness occur
symptoms do not get better within 7 days or are accompanied by fever

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredients (in Each 10 Ml) (Active ingredients (in each 10 mL))

Brompheniramine maleate 2 mg

Phenylephrine HCI 5 mg

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking any other oral nasal decongestant or stimulant
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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) runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily restores freer breathing through the nose ", "Purposes": "Antihistamine Nasal decongestant", "Directions": "do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to 11 years 10 mL every 4 hours children under 6 years do not use", "Do not use": "to sedate a child or to make a child sleepy 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.", "Package Label": "LEADER Children's Cold & Allergy Grape Flavor LEADER Children's Cold & Allergy Grape Flavor", "Other information": "each 10 mL contains : sodium 6 mg store between 20-25°C (68-77°F). Do not refrigerate. ", "Inactive ingredients": "anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "COMPARE TO CHILDREN'S DIMETAPP® COLD & ALLERGY active ingredients* Children Cold & Allergy Brompheniramine Maleate,2 mg Phenylephrine HCl, 5 mg Antihistamine Nasal Decongestant Grape Flavor Alcohol-Free For Ages 6 Years & Over Relieves Itchy, Watery Eyes Runny Nose Sneezing Stuffy Nose Itching of the Nose or Throat FL OZ (mL) Dosing Cup Included *This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com", "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": "nervousness, dizziness or sleeplessness occur 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 (1-800-222-1222) right away.", "Active ingredients (in each 10 mL)": "Brompheniramine maleate 2 mg Phenylephrine HCI 5 mg", "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 any other oral nasal decongestant or stimulant taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.443711 · Updated: 2026-03-14T23:02:33.495898