NDC Code(s) : 0536-1006-10, 0536-1006-35, 0536-1006-01
Packager : Rugby Laboratories

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aller-chlorChlorpheniramine Maleate TABLET
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-1006
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPHENIRAMINE MALEATE(UNII: V1Q0O9OJ9Z)
(CHLORPHENIRAMINE - UNII:3U6IO1965U) 		CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
Product Characteristics
Color yellow Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 44;194
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0536-1006-101000 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/12/1992
2NDC:0536-1006-352 in 1 CARTON 15/02/2019
212 in 1 BLISTER PACK Type 0: Not a Combination Product19/12/1992
3NDC:0536-1006-011 in 1 CARTON 19/12/1992
3100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product19/12/1992
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 12/19/1992

LABELER - Rugby Laboratories(079246066)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 pack(0536-1006)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(0536-1006), pack(0536-1006)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 manufacture(0536-1006)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(0536-1006)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(0536-1006)

PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-1006-10

4 Hour

Aller-chlor®

Chlorpheniramine Maleate  4 mg
Antihistamine

relieves:
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat

1000 Tablets

actual size

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

50844         REV0419C19416

Distributed by:
RUGBY® LABORATORIES
Indianapolis, IN 46268
(800) 616-2471
www.major-rugby.com

Rev. 06/25 R-17 Re-order No. 370296

Rugby 44-194 Rugby 44-194