NDC Code(s) : 55910-891-04
Packager : Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allergy Diphenhydramine Hydrochloride LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-891
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
GLYCERIN(UNII: PDC6A3C0OX)
POLOXAMER 407(UNII: TUF2IVW3M2)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
SUCROSE(UNII: C151H8M554)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55910-891-041 in 1 BOX 31/03/2018
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 03/31/2018 08/31/2027

LABELER - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)(068331990)

PRINCIPAL DISPLAY PANEL

Compare to active ingredient of Children's Benadryl® Allergy*

For Ages 6 to 11 Years

Children's

Allergy

Diphenhydramine HCI

Antihistamine 

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

Alcohol free

Provides allergy symptom relief

Bubble Gum Flavor

FOR AGES 6-11

Dosing Cup included

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl® Allergy

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 OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl 12.5 mg DOLLAR GENERAL HEALTH Children's Allergy Bubble Gum