FDA Label for Childrens Cold And Cough

Active Ingradients (In Each 10 Ml)

Brompheniramine maleate, USP 2 mg

Dextromethorphan HBr, USP 10  mg

Phenylephrine HCl, USP 5 mg

Purposes

Antihistamine

Cough Suppressant

Nasal decongestant

Uses

• temporarily relieves cough due to minor bronchial irritation as may occur 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

• 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, or  psychiatric, 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.

Ask A Doctor Before Use If You Have

• heart disease
• glaucoma
• diabetes
• thyroid disease
• high blood pressure
• difficulty in urination due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

• taking any other oral nasal decongestant or stimulant
• taking sedative or tranquilizers

When Using This Product

• do not take more than directed
• may cause drowsiness
• alcohol, sedatives, and tranquillizers may increase drowsiness
• avoid alcoholic beverages
• 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 improve within 7 days or are accompanied by fever
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs 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 (1-800-222-1222) right away.

Directions

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



Age	Dose
adults & children  12 years & 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 10 mg
• store at 20-25°C (68-77°F)
• measuring cup provided

Inactive Ingredients

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C Red #40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Questions Or Comments?

call (609) 860-2600 Mon - Fri 8:00 am to 4:30 pm est

Principal Display Panel

LEADER

NDC 70000-0631-1

Children's Cold & Cough Liquid

Brompheniramine Maleate

Dextromethorphan Hydrobromide

Phenylephrine Hydrochloride

Antihistamine 

Cough Suppressant

Nasal Decongestant
Grape 

Flavor

Relieves:

Stuffy Nose,

Runny Nose,

Sneezing,

Cough

Alcohol-Free

COMPARE TO CHILDREN'S DIMETAPP^®

COLD & COUGH

active ingredients*

4 FL OZ (118 mL)

LDR_577_Crt - ldr577crt3 30 2023