NDC Code(s) : 50844-455-08
Packager : L.N.K. International, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Allergy Acetaminophen, Chlorpheniramine maleate, Phenylephrine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-455
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U) 		CHLORPHENIRAMINE MALEATE2 mg
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
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)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCRALOSE(UNII: 96K6UQ3ZD4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape OVAL Size 17 mm
Flavor MENTHOL Imprint Code 44;455
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50844-455-082 in 1 CARTON 28/06/2005
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 06/28/2005

LABELER - L.N.K. International, Inc.(038154464)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 pack(50844-455)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(50844-455), pack(50844-455)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(50844-455)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(50844-455)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(50844-455)

PRINCIPAL DISPLAY PANEL

QUALITY
+ PLUS

NDC 50844-455-08

Allergy
Multi-Symptom

Acetaminophen
Chlorpheniramine maleate
Phenylephrine HCl

PAIN RELIEVER, ANTIHISTAMINE,
NASAL DECONGESTANT

• Headache       • Sinus Pressure
• Runny Nose    • Nasal Congestion
• Sneezing         • Itchy, Watery Eyes

24 Caplets

Pseudoephedrine Free

ACTUAL SIZE

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

50844 REV0818A45508

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive
Hauppauge, NY 11788
USA

Quality Plus 44-455C-AMS Quality Plus 44-455C-AMS