NDC Code(s) : 55315-313-04
Packager : Freds Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Childrens Dibromm Cold and CoughBrompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-313
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
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 Name Strength
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)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SORBITOL(UNII: 506T60A25R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55315-313-041 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 06/30/2024

LABELER - Freds Inc(005866116)

PRINCIPAL DISPLAY PANEL

6 + YEARS

CHILDREN'S

COLD & COUGH

BROMPHENIRAMINE MALEATE 2mg

Antihistamine

DEXTROMETHORPHAN HBr 10mg

Cough Suppressant

PHENYLEPHRINE HCl 5mg

Nasal Decongestant

Relieves:

  • Cough
  • Itchy, Watery Eyes
  • Runny Nose
  • Sneezing
  • Stuffy Nose
  • Itchy Nose or Throat

GRAPE FLAVOR

Alcohol Free

FL OZ (mL)

Dosing Cup Included

*Compare To Active Ingredients in Children's Dimetapp® Cold & Cough

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

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

DISTRIBUTED BY: fred's inc.

4300 NEW GETWELL RD, MEMPHIS TN, 38118

www.fredsinc.com

PRINCIPAL DISPLAY PANEL

Brompheniramine Maleate 2mg, Dextromethorphan Hbr 10mg, Phenylephrine HCI 5mgFred's Pharmacy Children's Cold & Cough