NDC Code(s) : 63941-012-04
Packager : Best Choice (Valu Merchandisers Company)

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Cold and AllergyBrompheniramine maleate, Phenylephrine HCl LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE(UNII: IXA7C9ZN03)
(BROMPHENIRAMINE - UNII:H57G17P2FN) 		BROMPHENIRAMINE MALEATE2 mg in 10 mL
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
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)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SORBITOL(UNII: 506T60A25R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63941-012-041 in 1 BOX 30/06/2015
1118 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 06/30/2015

LABELER - Best Choice (Valu Merchandisers Company)(868703513)

PRINCIPAL DISPLAY PANEL

Compare to the active ingredients in Childreb's Dimetapp® Cold & Allergy**

Children's

Dibromm Cold & Allergy

Brompheniramine maleate 2 mg

Antihistamine

Phenylephrine HCl 5 mg

Nasal decongestant

For relief of:

  • Itchy, watery eyes
  • Runny Nose
  • Sneezing
  • Stuffy nose
  • Itching of the nose or throat

For ages 6 years and over

Alcohol-free

Grape Flavor

Dosing Cup Included

FL OZ (mL)

**This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

PROUDLY DISTRIBUTED BY:

ASSOCIATED WHOLESALE GROCERS, INC.

KANSAS CITY, KANSAS 66106

PRINCIPAL DISPLAY PANEL

Brompheniramine maleate 2 mg, Phenylephrine HCl 5 mgBEST CHOICE Children's Cold & Allergy