NDC Code(s) : 55301-464-08
Packager : ARMY AND AIR FORCE EXCHANGE SERVICE

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allergy and Sinus HeadacheAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-464
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C RED NO. 40 ALUMINUM LAKE(UNII: 6T47AS764T)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color green Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code 44;464
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55301-464-082 in 1 CARTON 15/06/2005
112 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 Drug M012 06/15/2005

LABELER - ARMY AND AIR FORCE EXCHANGE SERVICE(001695568)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(55301-464), pack(55301-464)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(55301-464)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(55301-464)

PRINCIPAL DISPLAY PANEL

exchange✓select™

ALLERGY &
SINUS HEADACHE

Acetaminophen
Diphenhydramine HCl
Phenylephrine HCl

Pain Reliever
Antihistamine
Nasal Decongestant

Relieves
Sinus Headache, Sneezing,
Runny Nose, Itchy Throat,
Sinus Congestion, Sinus Pressure,
& Itchy, Watery Eyes

Actual Size

24 Caplets

✓quality
value

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

50844   REV1024L46408

"SATISFACTION GUARANTEED
OR YOUR MONEY BACK"
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.
Hauppauge, NY 11788
1-800-426-9391

Exchange Select 44-464 Exchange Select 44-464