NDC Code(s) : 0472-1201-06, 0472-1201-50
Packager : Actavis Mid Atlantic LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FeverALL Childrenacetaminophen SUPPOSITORY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-1201
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN120 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROGENATED PALM KERNEL OIL(UNII: FM8D1RE2VP)
PEG-100 STEARATE(UNII: YD01N1999R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0472-1201-066 in 1 BOX
2NDC:0472-1201-5050 in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018337 04/01/1980

PRINCIPAL DISPLAY PANEL

Children’s

Ages 3-6 years

120 mg

NDC 0472-1201-06

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

6 Rectal Suppositories

120 mg each

1