DIMETAPP PAEDIATRIC- brompheneramine maleate, pseduephedrine hydrochloride elixir

Dimetapp Paediatric by

Drug Labeling and Warnings

Dimetapp Paediatric by is a Otc medication manufactured, distributed, or labeled by Wyeth Consumer Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL - 118 ml Bottle Carton

READ DIRECTIONS CAREFULLY

37/5.8/0406

S2

Dimetapp®

Paediatric
Elixir

Relieves:

• Nasal Congestion
• Sneezing
• Runny Nose
• Sniffing

GREAT
GRAPE TASTE

ALCOHOL-FREE

4 FL OZ 118 ml

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)

INGREDIENTS AND APPEARANCE

DIMETAPP PAEDIATRIC 
brompheneramine maleate, pseduephedrine hydrochloride elixir

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0031-2251
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0031-2251-12	1 in 1 CARTON	09/14/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0031-2251-04	1 in 1 CARTON	08/08/2016
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 0031-2251-05	1 in 1 CARTON	08/08/2016
3		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
EXPORT ONLY		09/14/2015

Labeler - Wyeth Consumer Healthcare LLC (828831730)