mckesson cold & allergy drug facts

SPL v1

SPL

SPL Set ID e7a01146-6183-4dde-8acd-5a3c95dc555d

Route

oral

Published

Effective Date 2020-01-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

phenylephrine (5 mg) brompheniramine (2 mg)

Inactive Ingredients

anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water saccharin sodium sodium benzoate sorbitol

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

otc monograph final active Since 2006-09-11

Purpose

Antihistamine Nasal decongestant

How Supplied

Product: 50090-4840 NDC: 50090-4840-0 118 mL in a BOTTLE / 1 in a CARTON

Description

Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg

Medication Information

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

Purpose

Antihistamine Nasal decongestant

Directions

•
do not take more than 6 doses in any 24-hour period
•
measure only with dosage cup provided
•
keep dosage cup with product
•
mL = milliliter

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

Other Information

•
each 10 mL contains: sodium 4 mg
•
store at 20-25°C (68-77°F)

Inactive Ingredients

anhydrous 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 solution

How Supplied

Product: 50090-4840

NDC: 50090-4840-0 118 mL in a BOTTLE / 1 in a CARTON

Description

Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 5 mg

Purposes

Antihistamine

Nasal decongestant

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

Questions Or Comments?

1-800-719-9260

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 (1-800-222-1222).

Active Ingredients (in Each 10 Ml)

Brompheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 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

Phenylephrine Hcl, Brompheniramine Maleate

Ask A Doctor Or Pharmacist Before Use If You Are

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

Directions

•
do not take more than 6 doses in any 24-hour period
•
measure only with dosage cup provided
•
keep dosage cup with product
•
mL = milliliter

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

Other Information (Other information)

•
each 10 mL contains: sodium 4 mg
•
store at 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

anhydrous 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 solution

How Supplied (HOW SUPPLIED)

Product: 50090-4840

NDC: 50090-4840-0 118 mL in a BOTTLE / 1 in a CARTON

Purposes

Antihistamine

Nasal decongestant

Do Not Use (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

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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)

•
you get nervous, dizzy, or sleepless
•
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 right away (1-800-222-1222).

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

Brompheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 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

Phenylephrine Hcl, Brompheniramine Maleate (phenylephrine hcl, brompheniramine maleate)

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

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 • sneezing • itchy, watery eyes • 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 dosage cup provided • keep dosage cup with product • mL = milliliter age dose adults and children 12 years and over 20 mL every 4 hours children 6 to under 12 years 10 mL every 4 hours children under 6 years do not use", "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", "HOW SUPPLIED": "Product: 50090-4840 NDC: 50090-4840-0 118 mL in a BOTTLE / 1 in a CARTON", "Other information": "• each 10 mL contains: sodium 4 mg • store at 20-25°C (68-77°F)", "Inactive ingredients": "anhydrous 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 solution", "Questions or comments?": "1-800-719-9260", "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 (1-800-222-1222).", "Active ingredients (in each 10 mL)": "Brompheniramine maleate, USP 2 mg Phenylephrine HCl, USP 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 sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:02.669798 · Updated: 2026-03-14T22:55:55.934342