FDA Label for Childrens Cold Cough Dm

Active Ingredients (In Each 10 Ml)

Brompheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Purposes

Antihistamine

Cough suppressant

Uses

• •temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold
• •temporarily relieves these symptoms due to hay fever (allergic rhinitis):
• •runny nose
• •sneezing
• •itchy, watery eyes
• •itching of the nose or throat

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

• •trouble urinating due to an enlarged prostate gland
• •glaucoma
• •cough that occurs with too much phlegm (mucus)
• •a breathing problem such as emphysema or chronic bronchitis
• •cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers

When Using This Product

• •do not use more than directed
• •may cause marked drowsiness
• •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

cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign 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 right away (1-800-222-1222).

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 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 68°-77°F (20°-25°C)

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

Package/Label Principal Display Panel

P

FOR AGES 6 YEARS & OVER

CHILDREN’S

cold & cough DM

ANTIHISTAMINE, BROMPHENIRAMINE MALEATE

COUGH SUPPRESSANT,

DEXTROMETHORPHAN HBr

Safe and effective relief without phenylephrine.

Relief of:

• Runny nose

• Itchy, watery eyes

• Coughing, sneezing

GRAPE FLAVORED

ALCOHOL FREE

Compare to active ingredients in Dimetapp^® Cold & Cough.

4 FL OZ (118 mL)

26k-63-cold-and-cough-dm.jpg - 26k 63 cold and cough dm