NDC Code(s) : 69067-100-08
Packager : Foxland Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AcetaminophenACETAMINOPHEN LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69067-100
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
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
FD&C RED NO. 40(UNII: WZB9127XOA)
CHERRY(UNII: BUC5I9595W)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
SODIUM BENZOATE(UNII: OJ245FE5EU)
Water(UNII: 059QF0KO0R)
Product Characteristics
Color RED Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69067-100-08237 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 03/09/2016

PRINCIPAL DISPLAY PANEL

NDC 69067-100-08

See New Warnings Information
Rx Only

ACETAMINOPHEN
160 mg/5 mL

Liquid

Pain Reliever, Fever Reducer
Do not use if seal is broken or missing

237mL (8 fl oz)

Foxland
PHARMACEUTICALS, INC.

Principal Display Panel - 237 mL Bottle Label