CHILDRENS DIMETAPP COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl liquid 
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

Phenylephrine HCl , USP 5 mg

PURPOSES

Antihistamine

Nasal decongestant

USES

•
temporarily relieves 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
•
a breathing problem such as emphysema, asthma, or chronic bronchitis

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
•
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

•
you get nervous, dizzy, or sleepless
•
symptoms do not get better within 7 days or are accompanied by fever

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, 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

NDC 0031-2235-13

Children's
Dimetapp®

BROMPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)

Cold
& Allergy

Relieves Nasal Symptoms

•
Stuffy Nose
•
Runny Nose
•
Sneezing

Plus Other Symptoms

•
Itchy, Watery Eyes

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 ALLERGY 
brompheniramine maleate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2235
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 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)  
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
ColorPURPLE (purple liquid) Score    
ShapeSize
FlavorGRAPE (grape flavor and odor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2235-131 in 1 CARTON02/07/200707/31/2021
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:0031-2235-191 in 1 CARTON02/07/200704/30/2022
2237 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 finalpart34102/07/200704/30/2022
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2022
Document Id: 5e2f8778-6595-4885-b0e4-4b94c0529271
Set id: 9e18bd92-f305-483d-cd61-f2a087315db0
Version: 11
Effective Time: 20220105
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC