NDC Code(s) : 0472-1200-06, 0472-1200-50
Packager : Actavis Mid Atlantic LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FeverALL Infantsacetaminophen SUPPOSITORY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-1200
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN80 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:0472-1200-066 in 1 BOX
2NDC:0472-1200-5050 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

Infants’

Ages 6-36 months

80 mg

NDC 0472-1200-06

FeverAll®

Acetaminophen Suppositories

Pain reliever/fever reducer

6 Rectal Suppositories

80 mg each

1