CHILDRENS DIMETAPP MULTI-SYMPTOM COLD RELIEF DYE-FREE- brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl 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)

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 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
measure only with dosage cup provided
keep dosage cup with product
ml = milliliter
agedose

adults and children 12 years and 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 6 mg
store at 20-25°C (68-77°F)

Inactive ingredients

anhydrous citric acid, artificial flavor, 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

For most recent product information, visit www.dimetapp.com

Distributed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL

NDC 0031-2295-12

Children's
Dimetapp®

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

Multi-Symptom
Cold Relief
DYE-FREE

Relieves Nasal Symptoms

1.
Stuffy Nose
2.
Runny Nose
3.
Sneezing

Plus Other Symptoms

1.
Itchy, Watery Eyes
2.
Cough

For Ages
6 Yrs.
& Over

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

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton
CHILDRENS DIMETAPP MULTI-SYMPTOM COLD RELIEF DYE-FREE 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2295
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorYELLOW (colorless to pale yellow, clear liquid) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2295-121 in 1 CARTON06/01/201609/30/2021
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 finalpart34106/01/201609/30/2021
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2022
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC