NDC Code(s) : 41520-376-26, 41520-376-28
Packager : American Sales Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CareOne Childrens Pain and FeverAcetaminophen SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41520-376
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)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
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 BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41520-376-261 in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:41520-376-281 in 1 CARTON
2147 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/13/2004

PRINCIPAL DISPLAY PANEL

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

CHILDREN’S PAIN & FEVER

Pain Reliever/Fever Reducer

Acetaminophen 160 mg per 5 mL

Oral Suspension

BUBBLE GUM FLAVOR

FOR AGES 2-11 YEARS

Fast, Effective Relief of Children’s Pain and Fever

Alcohol Free

Aspirin Free

Ibuprofen Free

See New Warnings

4 FL OZ (118 mL)

CareOne Children