FDA Label for Cold And Cough Childrens

Active Ingredients (In Each 10 Ml)

Brompheniramine Maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring 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)
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • temporarily restores freer breathing through the nose
  
  

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. 

Ask A Doctor Before Use If You Have

• heart disease
• thyroid disease
• high blood pressure
• diabetes
• glaucoma
• trouble urinating 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 sedatives or tranquilizers

When Using This Product,

• do not use more than directed
• marked 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 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 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 (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 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

Other Information

• each 10 mL contains: sodium 5 mg 
• store between 20-25°C (68-77°F). Do not refrigerate.

Inactive Ingredients

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

Principal Display Panel

Compare to the active ingredients in Children's Dimetapp® Cold & Cough*

6 YEARS & OLDER

CHILDREN'S

COLD & COUGH

BROMPHENIRAMINE MALEATE 2 mg

DEXTROMETHORPHAN HBr 10 mg

PHENYLEPHRINE HCl 5 mg

ANTIHISTAMINE

COUGH SUPPRESSANT

NASAL DECONGESTANT

relieves:

cough • itchy, watery eyes

runny nose • sneezing

stuffy nose

itching of the nose or throat

GRAPE FLAVOR

DOSAGE CUP INCLUDED

FL OZ (mL)

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

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

DISTRIBUTED BY:

RITE AID

30 HUNTER LANE

CAMP HILL, PA 17011

www.riteaid.com

Product Label