NDC Code(s) : 70253-453-07, 70253-453-44
Packager : NASH-FINCH COMPANY

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Suphedrine PEPhenylephrine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70253-453
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
DEXTROSE MONOHYDRATE(UNII: LX22YL083G)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
FD&C RED NO. 40(UNII: WZB9127XOA)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 44;453
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70253-453-071 in 1 CARTON
136 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:70253-453-441 in 1 CARTON
218 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/06/2004 04/02/2018

PRINCIPAL DISPLAY PANEL

SAFETY SEALED

Relieves Nasal and
 Sinus Congestion Due
 to Colds and Allergies

Our Family®
Quality Care Since 1904

Compare to the  Active ingredient of  Sudafed PE®*

Suphedrine PE
PHENYLEPHRINE HYDROCHLORIDE
NASAL DECONGESTANT
WITHOUT DROWSINESS

18 TABLETS

Does not contain Pseudoephedrine

1 Pill Per Dose
 10 mg EACH

TAMPER EVIDENT: DO NOT USE IF CATON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Sudafed PE®.
50844         REV1111E45344

DISTRIBUTED BY:
NASH FINCH COMPANY ©2004, 1996
NFC BRANDS
7600 FRANCE AVE S, MPLS, MN 55435
www.ourfamilyfoods.com      NF16559

Our Family 44-453Our Family 44-453