NDC Code(s) : 70253-235-08, 70253-235-15
Packager : NASH-FINCH COMPANY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pain Reliever PMAcetaminophen and Diphenhydramine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70253-235
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POVIDONES(UNII: FZ989GH94E)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code 44;235
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70253-235-081 in 1 CARTON
124 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
2NDC:70253-235-151 in 1 CARTON
250 in 1 BOTTLE, PLASTIC 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 05/15/1994 07/13/2018

PRINCIPAL DISPLAY PANEL

For pain with sleeplessness
Pain Reliever
Nighttime Sleep-Aid

Our Family®
Quality Care Since 1904

Compare to the
Active Ingredients
in Extra Strength
Tylenol® PM*

PAIN RELIEVER PM
ACETAMINOPHEN 500 mg, DIPHENHYDRAMINE HCl 25 mg

EXTRA STRENGTH

50 CAPLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol® PM.

DISTRIBUTED BY:
NASH FINCH COMPANY ©2004,1996
NFC BRANDS,
7600 FRANCE AVE S, MPLS, MN 55435
www.ourfamilyfoods.com     NF17206
50844     REV0512E23515

OurFamily44-235OurFamily44-235