DIMETAPP PAEDIATRIC- brompheneramine maleate, pseduephedrine hydrochloride elixir 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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Dimetapp® Paediatric Elixir

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

READ DIRECTIONS CAREFULLY

37/5.8/0406

S2

Dimetapp®

Paediatric
Elixir

Relieves:

1.
Nasal Congestion
2.
Sneezing
3.
Runny Nose
4.
Sniffing

GREAT
GRAPE TASTE

ALCOHOL-FREE

4 FL OZ 118 ml

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton - Adult

Dimetapp®
Elixir
NASAL DECONGESTANT
ANTIHISTAMINE

GREAT GRAPE TASTE
FOR CHILDREN & ADULTS

RELIEVES COLD AND
ALLERGY SYMPTOMS

NASAL CONGESTION

RUNNY NOSE

ITCHY, WATERY EYES

SNEEZING

4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton - Adult
DIMETAPP PAEDIATRIC 
brompheneramine maleate, pseduephedrine hydrochloride elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2251
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2251-121 in 1 CARTON09/14/2015
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0031-2251-041 in 1 CARTON08/08/2016
2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0031-2251-051 in 1 CARTON08/08/2016
3118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only09/14/2015
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2024
Document Id: 02e8d257-8541-42f0-9cb1-af9b02edea02
Set id: e180b654-0e83-4874-b947-30d19d2bb7d8
Version: 6
Effective Time: 20240111
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC