NDC Code(s) : 63940-175-26
Packager : Harmon Stores Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

harmon face values pain and feverAcetaminophen SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63940-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
CALCIUM SULFATE(UNII: WAT0DDB505)
CARRAGEENAN(UNII: 5C69YCD2YJ)
FD&C RED NO. 40(UNII: WZB9127XOA)
GLYCERIN(UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP(UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBITOL(UNII: 506T60A25R)
SODIUM PHOSPHATE, TRIBASIC(UNII: A752Q30A6X)
Product Characteristics
Color RED (opaque) Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63940-175-261 in 1 CARTON
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 not final part343 12/18/2011

PRINCIPAL DISPLAY PANEL

Compare Ours to the Active Ingredient in Children's Tylenol® Oral Suspension

For Ages 2-11 Years

Children's

PAIN & FEVER

Acetaminophen

160 mg per 5 mL

Oral Suspension

Fever Reducer / Pain Reliever

cherry flavored

Dosage Cup Enclosed

Alcohol Free

Aspirin Free

Ibuprofen Free

4 FL OZ (118 mL) (160 mg per 5 mL)

Harmon Face Values Children