CHILDRENS DIMETAPP COLD AND COUGH- brompheniramine maleate, dextromethorphan hydrobromide and phenylephrine hydrochloride liquid 
Richmond Division of Wyeth

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Children's Dimetapp Cold & Cough
(brompheniramine maleate, dextromethorphan HBr, and phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Brompheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl , USP 2.5 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

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, 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
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • 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
  • 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

  • you get nervous, dizzy, or sleepless
  • symptoms do not get better 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 right away.

DIRECTIONS

  • do not take more than 6 doses in any 24-hour period
agedose
adults and children 12 years and over 4 tsp every 4 hours
children 6 to under 12 years2 tsp every 4 hours
children under 6 yearsdo not use

OTHER INFORMATION

  • each teaspoon contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Children's
Dimetapp®

BROMPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)
PHENYLEPHRINE HCl (Nasal Decongestant)

Cold
& Cough

Relieves Nasal Symptoms

✓ Stuffy Nose
✓ Runny Nose
✓ Sneezing

Plus Other Symptoms

✓ Itchy, Watery Eyes
✓ Cough

For Ages
6 Yrs.
& Over

4 FL OZ (118 ml) alcohol-free • grape flavor

Principal Display Panel - 118 mL Bottle Carton
CHILDRENS DIMETAPP COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0031-2234
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorPURPLE (purple liquid) Score    
ShapeSize
FlavorGRAPE (grape flavor and odor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2234-131 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:0031-2234-191 in 1 CARTON
2237 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/23/2006
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Canada Inc.246770197ANALYSIS(0031-2234), LABEL(0031-2234), MANUFACTURE(0031-2234), PACK(0031-2234)

Revised: 4/2013
Document Id: df72a60f-07e8-4d93-b032-934ccb3577dd
Set id: 7a83374a-1f56-4f40-9227-3ce55d30a903
Version: 4
Effective Time: 20130410
 
Richmond Division of Wyeth