NDC Code(s) : 63940-590-16
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:63940-590
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)
CALCIUM SULFATE(UNII: WAT0DDB505)
CARRAGEENAN(UNII: 5C69YCD2YJ)
GLYCERIN(UNII: PDC6A3C0OX)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SORBITOL(UNII: 506T60A25R)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, TRIBASIC(UNII: A752Q30A6X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63940-590-161 in 1 CARTON
159 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 04/17/2012

PRINCIPAL DISPLAY PANEL

See New Warnings

Compare Ours to the Active Ingredient in Infants’ Tylenol®

For Ages 2-3 Years

Infants’

PAIN & FEVER

Acetaminophen

160 mg per 5 mL

Fever Reducer / Pain Reliever

Suspension Liquid

Dye-Free

Non-Staining

cherry flavored

Pediatrician Preferred Dosing System

Alcohol Free

Aspirin Free

Ibuprofen Free

Gluten Free

Use only with enclosed syringe. See side panel for more information.

2 FL OZ (59 mL)

InfantsInfants