CHILDRENS DIMETAPP LONG ACTING COUGH PLUS COLD- chlorpheniramine maleate, dextromethorphan hbr solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredients (in each 10 ml)

Chlorpheniramine maleate, USP 2.0 mg

Dextromethorphan HBr, USP 15 mg

Purposes

Antihistamine

Cough suppressant

Uses

•
temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
•
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
•
runny nose
•
sneezing
•
itchy, watery eyes
•
itching of the nose or throat

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

•
trouble urinating due to an enlarged prostate gland
•
glaucoma
•
a cough that occurs with too much phlegm (mucus)
•
a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis 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
•
marked drowsiness may occur
•
avoid alcoholic drinks
•
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 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 4 doses in any 24-hour period
•
measure only with dosage cup provided
•
keep dosage cup with product
•
ml = milliliter
agedose

12 years and over

20 ml every 6 hours

6 to under 12 years

10 ml every 6 hours

under 6 years

do not use

Other information

•
each 10 ml contains: sodium 6 mg
•
store at 20-25°C (68-77°F)

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

Distributed by:
Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

NDC 0031-2238-13

Children's
Dimetapp®

CHLORPHENIRAMINE MALEATE (Antihistamine)
DEXTROMETHORPHAN HBr (Cough Suppressant)

up to
8 hours
of cough
control

Long Acting
Cough
Plus Cold

Relieves Nasal Symptoms

•
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 LONG ACTING COUGH PLUS COLD 
chlorpheniramine maleate, dextromethorphan hbr solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2238
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2238-131 in 1 CARTON03/04/200511/30/2020
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/04/200511/30/2020
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 6/2021
Document Id: 30881731-2300-41c7-a079-9ef8773e542f
Set id: 059a3e6e-ea98-b0c5-ba27-b7cbbdedc917
Version: 8
Effective Time: 20210609
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC