NDC Code(s) : 55910-464-08
Packager : DOLGENCORP, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allergy Plus Sinus HeadacheAcetaminophen, Diphenhydramine HCl and Phenylephrine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-464
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:55910-464-082 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 - DOLGENCORP, LLC(068331990)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(55910-464), pack(55910-464)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(55910-464)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(55910-464)

PRINCIPAL DISPLAY PANEL

DG™| health

Allergy Plus
 Sinus Headache

Acetaminophen 325 mg • Pain Reliever
Diphenhydramine HCl 12.5 mg • Antihistamine
Phenylephrine HCl 5 mg • Nasal Decongestant

Helps Relieve:
• Sinus congestion, pain & headache
• Sneezing
• Runny nose
• Itchy, watery eyes

24 Caplets

Actual Caplet Size

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

50844
REV1024F46408

DISTRIBUTED BY
OLD EAST MAIN CO.
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

100%
Satisfaction
Guaranteed!
(888)309-9030
Dollar General 44-464

Dollar General 44-464