NDC Code(s) : 37808-379-26
Packager : H E B

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AllergyDiphenhydramine HCl SOLUTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-379
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)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
POLOXAMER 407(UNII: TUF2IVW3M2)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
Product Characteristics
Color RED (Bluish-Red) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37808-379-261 in 1 CARTON 15/07/1987
1118 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
OTC Monograph Drug M012 07/15/1987

LABELER - H E B(007924756)

PRINCIPAL DISPLAY PANEL

Compare to Children’s Benadryl® Allergy active ingredient

H-E-B®

Children’s Allergy

Diphenhydramine HCl 12.5 mg/5 mL Oral Solution

Antihistamine

For Ages 6+

Relief of:

• Runny Nose

• Sneezing

• Itchy, Watery Eyes

• Itchy Throat or Nose

Alcohol Free

Cherry Flavor

4 FL OZ (118 mL)

Children